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):
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).
On November 5, 2026, Quoin
Pharmaceuticals Ltd. (the “Company”) issued a press release announcing its financial results for the quarter ended September 30,
2026. A copy of the press release is furnished with this Current Report on Form 8-K as Exhibit 99.1 and is incorporated herein by reference.
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.
(d) Exhibits.
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.
Exhibit 99.1
Quoin Pharmaceuticals Provides Corporate Update
and Reports Third Quarter 2026 Financial Results
– Reports Positive Interim Data from Ongoing Phase 2/3 Study
of QRX003 in Netherton Syndrome; Primary and Key Secondary Endpoints Achieved Statistical Significance Versus Pre-Specified Alpha-Adjusted
Target
–Announces Private Placement Financing of Up to $50.0 Million
with Healthcare-Focused Institutional Investors
– FDA Clears First-Ever IND for Peeling Skin Syndrome (PSS),
Grants Rare Pediatric Disease and Fast Track Designations to QRX003 for PSS; EMA Grants Orphan Drug Designation to QRX003 for PSS Subsequent
to Quarter End
– Advances QRX009 Topical Rapamycin Platform Toward Clinical
Testing in a Number of Indications
– Expands NETHERTON NOW Awareness Campaign with New Video
Featuring a Pediatric Critical Care Physician and Her Daughter
–Peer-Reviewed Paper on QRX003 for Netherton Syndrome Published
in Dermatology and Therapy Subsequent to Quarter End
ASHBURN, Va., Nov. 05, 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 third quarter
ended September 30, 2026.
“The third quarter substantially strengthened Quoin’s clinical,
regulatory and financial foundation for long-term growth. Interim clinical results from our Phase 2/3 study of QRX003 in Netherton Syndrome
demonstrated statistical significance for the primary and key secondary endpoints, representing what we believe is the first ever overall
positive data set published for this disease. In addition, QRX003 was awarded Rare Pediatric Disease and Fast Track Designations in Peeling
Skin Syndrome. Finally, our successful August private placement has provided us with funding to fully complete the development of QRX003
for Netherton Syndrome, whilst enabling us to selectively invest in the advancement of our pipeline products. We were pleased to see the
participation of both new and existing investors in the raise,” said Dr. Michael Myers, Chief Executive Officer and Co-Founder of
Quoin Pharmaceuticals. “Following quarter end, QRX003 was awarded EU Orphan Drug Designation in Peeling Skin Syndrome, and the publication
of our paper in Dermatology and Therapy, on a pediatric case report, has added peer-reviewed clinical evidence to the growing body of
data supporting QRX003 as a potentially safe and effective treatment for Netherton Syndrome.”
Dr. Myers added, “Our priorities for the coming months are very
clear. We expect to complete recruitment in our Netherton Syndrome study by year end and report topline data in the second quarter of
2027. We also plan to initiate the first-ever formal clinical study in Peeling Skin Syndrome before year end whilst simultaneously advancing
our QRX009 topical rapamycin program towards clinical testing in early 2027. These are indeed exciting times for Quoin as we continue
to move closer towards achieving our goal of delivering the first approved treatment for Netherton Syndrome.”
QRX003 – Netherton Syndrome
Positive Interim Data from Phase 2/3 Study CL-QRX003-004. On
August 28, 2026, Quoin reported positive interim results from CL-QRX003-004, its ongoing Phase 2/3 study of QRX003 4% lotion in patients
with Netherton Syndrome. In the interim analysis of the first six participants to complete 12 weeks of treatment, four of six (66.7%)
achieved the primary endpoint of a 1-grade or greater improvement in Investigator Global Assessment (p=0.0087 vs. a pre-specified alpha
of 0.0215). The key secondary endpoint, a Global Statistical Test of Global Impression of Change, also achieved statistical significance
at Week 12 (p=0.0070 vs. a pre-specified alpha of 0.0215). All three participants with moderate to severe pruritus at baseline achieved
a 3-grade or greater improvement in the Worst Itch Numeric Rating Scale at Week 12, with one participant achieving a greater than 6-grade
improvement. No treatment-related serious adverse events were reported. Quoin expects to complete recruitment of all 20 participants by
the end of 2026 and to report topline data in the second quarter of 2027.
Corporate and Financing
Private Placement of Up to $50.0 Million. On August 28, 2026,
Quoin announced a private placement with new and existing healthcare-focused institutional investors for up to approximately $50.0 million
in gross proceeds, including initial upfront funding of approximately $30.8 million and up to an additional approximately $19.2 million
upon the potential cash exercise of accompanying ordinary warrants.
QRX003 – Peeling Skin Syndrome
First-Ever IND for Peeling Skin Syndrome Cleared by FDA. On
July 9, 2026, Quoin announced that the FDA had cleared its IND for QRX003 in Peeling Skin Syndrome (PSS), the first IND ever submitted
to the FDA for the disease.
Rare Pediatric Disease and Fast Track Designations Granted by FDA.
On September 8, 2026, Quoin announced that the FDA had granted Rare Pediatric Disease (RPD) Designation to QRX003 for PSS, the second
RPD designation for QRX003 following Netherton Syndrome. On September 22, 2026, Quoin announced that the FDA had granted Fast Track Designation
to QRX003 for PSS, the first Fast Track Designation ever granted for a PSS therapy.
EMA Orphan Drug Designation Granted. Subsequent to quarter end,
on October 14, 2026, Quoin announced that the European Medicines Agency had granted Orphan Drug Designation to QRX003 for PSS. If approved
for marketing in the European Union, QRX003 will be granted 10 years of market exclusivity with respect to similar medicines for the treatment
of PSS. Across Netherton Syndrome and PSS, QRX003 now holds eight regulatory designations from the FDA, the EMA and Japan’s MHLW.
The planned Phase 2/3 study in PSS, the first-ever company-sponsored
formal clinical study for the disease, is expected to enroll up to 12 pediatric and adult patients in the United States and Europe and
to initiate before the end 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.
Awareness and Advocacy
New NETHERTON NOW Video Released. On September 10, 2026, Quoin
released the latest episode of its NETHERTON NOW video series, featuring Laura Wright-Sexton, MD, a board-certified pediatric critical
care physician, and her daughter Aminah. The episode explores the daily realities of raising a child with Netherton Syndrome and its impact
on the whole family. NETHERTON NOW is an awareness campaign created by Quoin to increase visibility of Netherton Syndrome among the general
public, treating physicians, the patient community, and policy and lawmakers. This video is the sixth in the NETHERTON NOW series, and
cumulatively the videos have been viewed more than 2.8 million times with over 28 million impressions.
Peer-Reviewed Paper Published in Dermatology and Therapy. Subsequent
to quarter end, on October 20, 2026, Quoin announced publication of a peer-reviewed paper introducing QRX003 and its mechanism of action
in Netherton Syndrome. The paper was published online on October 13, 2026, following acceptance announced on October 6, 2026. It includes
a case report from Professor Alan Irvine, Children’s Health Ireland and Trinity College Dublin, describing a pediatric patient treated
with QRX003 under Quoin’s Pediatric Compassionate Use Program. The patient’s IGA score improved from 4 (severe) at baseline
to 0 (clear) by eight months, and the patient remained mostly at IGA 0 over 21 months of treatment. No adverse events considered treatment-related
were reported.
Financial Highlights
Quoin had approximately $33.2 million in cash, cash equivalents, and
marketable securities as of September 30, 2026.
Net loss for the quarter ended September 30, 2026, was approximately
$4.9 million, compared to approximately $3.9 million for the quarter ended September 30, 2025. Net loss for the nine months ended September
30, 2026, was approximately $15.2 million, compared to approximately $11.5 million for the nine months ended September 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 September 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: the Company’s
clinical, regulatory and financial foundation for long-term growth; the August 2026 private placement providing funding to fully complete
the development of QRX003 for Netherton Syndrome while enabling the Company to selectively invest in the advancement of its pipeline products;
the potential receipt of up to approximately $19.2 million of additional gross proceeds upon the cash exercise of the ordinary warrants
issued in the private placement; QRX003 as a potentially safe and effective treatment for Netherton Syndrome; completing recruitment of
all 20 participants in the Phase 2/3 study of QRX003 in Netherton Syndrome by the end of 2026 and reporting topline data from that study
in the second quarter of 2027; moving closer towards the Company’s goal of delivering the first approved treatment for Netherton
Syndrome; initiating the planned Phase 2/3 study of QRX003 in Peeling Skin Syndrome before the end of 2026, and that study enrolling up
to 12 pediatric and adult patients in the United States and Europe; QRX003 being granted 10 years of market exclusivity in the European
Union with respect to similar medicines for the treatment of Peeling Skin Syndrome, if approved for marketing in the European Union; advancing
the QRX009 topical rapamycin platform toward clinical testing in early 2027, including planned investigator-led studies in Pachyonychia
Congenita, Gorlin Syndrome and Tuberous Sclerosis Complex, and submitting an IND to the FDA for an additional indication before the end
of 2026; the Company’s belief that its current cash position will fund operations into 2028; 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, Angiofibromas 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
QUOIN PHARMACEUTICALS LTD.
Condensed Consolidated Balance Sheets
| | |
September 30, | | |
December 31, | |
| | |
2026 | | |
2025 | |
| | |
(unaudited) | | |
| |
| ASSETS | |
| | |
| |
| Current assets: | |
| | | |
| | |
| Cash and cash equivalents | |
$ | 10,099,800 | | |
$ | 3,818,096 | |
| Investments | |
| 23,083,738 | | |
| 14,927,165 | |
| Prepaid expenses and other current assets | |
| 1,216,529 | | |
| 1,261,974 | |
| Total current assets | |
| 34,400,067 | | |
| 20,007,235 | |
| | |
| | | |
| | |
| Prepaid expenses - long term | |
| 38,643 | | |
| - | |
| Intangible assets, net | |
| 308,334 | | |
| 383,334 | |
| Total assets | |
$ | 34,747,044 | | |
$ | 20,390,569 | |
| | |
| | | |
| | |
| LIABILITIES AND SHAREHOLDERS' EQUITY | |
| | | |
| | |
| Current liabilities: | |
| | | |
| | |
| Accounts payable | |
$ | 1,578,247 | | |
$ | 1,262,222 | |
| Accrued expenses | |
| 2,597,281 | | |
| 2,538,457 | |
| Accrued interest and financing expense | |
| - | | |
| 1,146,251 | |
| Due to officers - short term | |
| 600,000 | | |
| 600,000 | |
| Total current liabilities | |
| 4,775,528 | | |
| 5,546,930 | |
| | |
| | | |
| | |
| Due to officers - long term | |
| 1,273,733 | | |
| 1,723,733 | |
| Total liabilities | |
$ | 6,049,261 | | |
$ | 7,270,663 | |
| | |
| | | |
| | |
| Commitments and contingencies | |
| | | |
| | |
| | |
| | | |
| | |
| Shareholders' equity: | |
| | | |
| | |
| Ordinary shares, no par value per share,
5,000,000,000 authorized at September 30, 2026 and December 31, 2025, respectively - 168,145,655 (4,804,162 ADSs) ordinary shares
issued and outstanding at September 30, 2026 and 52,441,360 (1,498,325 ADSs) ordinary shares issued and outstanding at December 31,
2025 | |
$ | - | | |
$ | - | |
| | |
| | | |
| | |
| Accumulated other comprehensive income (loss) | |
| 2,134 | | |
| (613 | ) |
| Additional paid in capital | |
| 114,905,632 | | |
| 84,090,966 | |
| Accumulated deficit | |
| (86,209,983 | ) | |
| (70,970,447 | ) |
| Total shareholders' equity | |
| 28,697,783 | | |
| 13,119,906 | |
| | |
| | | |
| | |
| Total liabilities and shareholders' equity | |
$ | 34,747,044 | | |
$ | 20,390,569 | |
QUOIN
PHARMACEUTICALS LTD.
Condensed
Consolidated Statements of Operations and Other Comprehensive Loss (Unaudited)
| | |
Three months ended September 30, | | |
Nine months ended September 30, | |
| | |
2026 | | |
2025 | | |
2026 | | |
2025 | |
| Operating expenses | |
| | | |
| | | |
| | | |
| | |
| General and administrative | |
$ | 2,267,412 | | |
$ | 1,738,751 | | |
$ | 5,811,266 | | |
$ | 5,064,383 | |
| Research and development | |
| 2,655,600 | | |
| 2,281,174 | | |
| 9,716,530 | | |
| 6,705,898 | |
| Total operating expenses | |
| 4,923,012 | | |
| 4,019,925 | | |
| 15,527,796 | | |
| 11,770,281 | |
| | |
| | | |
| | | |
| | | |
| | |
| Other (income) and expenses | |
| | | |
| | | |
| | | |
| | |
| Unrealized (gain) loss | |
| 72,865 | | |
| (9,494 | ) | |
| 84,580 | | |
| (3,616 | ) |
| Realized and accrued interest income | |
| (125,118 | ) | |
| (62,266 | ) | |
| (372,840 | ) | |
| (310,383 | ) |
| Total other income | |
| (52,253 | ) | |
| (71,760 | ) | |
| (288,260 | ) | |
| (313,999 | ) |
| Net loss | |
$ | (4,870,759 | ) | |
$ | (3,948,165 | ) | |
$ | (15,239,536 | ) | |
$ | (11,456,282 | ) |
| | |
| | | |
| | | |
| | | |
| | |
| Other comprehensive loss | |
| | | |
| | | |
| | | |
| | |
| Foreign currency translation | |
| 2,716 | | |
| - | | |
| 2,747 | | |
| - | |
| Comprehensive loss | |
$ | (4,868,043 | ) | |
$ | (3,948,165 | ) | |
$ | (15,236,789 | ) | |
$ | (11,456,282 | ) |
| | |
| | | |
| | | |
| | | |
| | |
| Loss per ADS | |
| | | |
| | | |
| | | |
| | |
| Loss per ADS | |
| | | |
| | | |
| | | |
| | |
| Basic | |
$ | (0.97 | ) | |
$ | (6.71 | ) | |
$ | (4.26 | ) | |
$ | (19.50 | ) |
| Fully-diluted | |
$ | (0.97 | ) | |
$ | (6.71 | ) | |
$ | (4.26 | ) | |
$ | (19.50 | ) |
| | |
| | | |
| | | |
| | | |
| | |
| Weighted average number of ADSs outstanding | |
| | | |
| | | |
| | | |
| | |
| Basic | |
| 5,042,201 | | |
| 588,166 | | |
| 3,576,795 | | |
| 587,561 | |
| Fully-diluted | |
| 5,042,201 | | |
| 588,166 | | |
| 3,576,795 | | |
| 587,561 | |
