Executive Summary

Q4 2024 net loss was $2.31M, modestly higher year over year ($2.05M in Q4 2023), while loss per ADS narrowed to $0.35 vs $2.08 in Q4 2023 due to share count changes .
Cash, cash equivalents and marketable securities were $14.1M at December 31, 2024; runway extended to the second quarter of 2026, aided by a $6.8M public offering in December 2024 .
Clinical execution advanced: FDA cleared a whole-body QRX003 study (up to 8 subjects, >80% BSA for 12 weeks) and interim data across studies showed rapid improvement and reduced disease severity with no reported adverse events .
Pipeline expansion continued with topical rapamycin IP filings; management emphasized 2024 as its most significant year and highlighted regulatory submission ambitions tied to whole-body data .
Near-term stock reaction catalysts: commencement and data from the whole-body study, pediatric cohort progress, and additional site activations (UK, Saudi Arabia) .

What Went Well and What Went Wrong

What Went Well

FDA clearance for a whole-body QRX003 study, representing the most extensive clinical application to date and intended to support regulatory approval submissions .
Interim clinical data indicated significant improvements across endpoints (e.g., MIASI reduced from 18 to 4 in 6 weeks; IGA improved from ‘moderate’ to ‘mild’; pruritus reduced from 7/11 to 4) with no adverse events reported .
Management tone and strategic vision: “2024 was without a doubt the most significant year in Quoin’s history… we remain steadfast in our mission to develop the first FDA-approved treatment for Netherton Syndrome” (CEO Michael Myers) .

What Went Wrong

Net loss increased year over year in Q4 ($2.31M vs $2.05M), reflecting higher operating expenses; total quarterly OpEx rose to $2.41M vs $2.22M in Q4 2023 .
Limited quantitative revenue/margin disclosures typical of clinical-stage companies; comparisons to Wall Street estimates are unavailable (no consensus retrieved) .
Trial execution risk remains: forward-looking statements caution potential delays, recruitment challenges, and uncertainty that data will be sufficiently robust for NDA filing .

Financial Results

Quarterly P&L (Sequential)

Metric	Q2 2024	Q3 2024	Q4 2024
Net Loss ($USD)	$(1,974,033)	$(2,349,885)	$(2,311,274)
Loss per ADS ($)	$(0.39)	$(0.47)	$(0.35)
General & Administrative ($USD)	$1,617,769	$1,357,715	$1,410,717
Research & Development ($USD)	$519,349	$1,170,287	$994,344
Total Operating Expenses ($USD)	$2,137,118	$2,528,002	$2,405,061

Year over Year (Q4)

Metric	Q4 2023	Q4 2024
Net Loss ($USD)	$(2,049,878)	$(2,311,274)
Loss per ADS ($)	$(2.08)	$(0.35)
General & Administrative ($USD)	$1,385,276	$1,410,717
Research & Development ($USD)	$832,391	$994,344
Total Operating Expenses ($USD)	$2,217,667	$2,405,061

Balance Sheet Snapshot

Metric	Jun 30 2024	Sep 30 2024	Dec 31 2024	Dec 31 2023
Cash & Cash Equivalents ($USD)	$2,845,126	$3,116,750	$3,623,343	$2,401,198
Investments ($USD)	$9,725,463	$7,190,138	$10,433,535	$8,293,663
Total Current Assets ($USD)	$13,221,285	$10,497,429	$14,926,004	$11,285,895
Total Shareholders’ Equity ($USD)	$7,478,336	$5,441,681	$9,204,673	$5,664,016

Notes:

No revenue/margin lines were disclosed in the company’s Q2–Q4 press materials; margin analysis is not meaningful for a clinical-stage entity .
Cash, cash equivalents and marketable securities totaled ~$14.1M at 12/31/24, consistent with balance sheet sums ($3.62M cash + $10.43M investments) .

KPIs (Clinical and Operational)

KPI	Q2 2024	Q3 2024	Q4 2024
International NS site expansion	Saudi Arabia site planned; EU CRO engaged	Two UK sites announced; further EU expansion planned	FDA cleared whole-body study (8 subjects, >80% BSA)
Pediatric NS assessment	—	Initiated pediatric assessment; additional Spain subjects planned (up to three)	Rapid improvements in pediatric subject with whole-body dosing; no adverse events
Interim efficacy signals	—	—	MIASI from 18 to 4 in 6 weeks; pruritus from 7 to 4; IGA ‘moderate’ to ‘mild’
Cash runway	Late 2025	Late 2025	Extended to Q2 2026

Segment breakdown: Not applicable.

Guidance Changes

Metric	Period	Previous Guidance	Current Guidance	Change
Cash Runway	Corporate (funding horizon)	“Into late 2025” (Q2/Q3 2024 updates)	“Into the second quarter of 2026” (post Dec 2024 offering)	Raised/Extended
Whole-Body QRX003 Study	NS clinical program	Not cleared/announced plans	FDA cleared; up to 8 subjects, twice-daily, >80% BSA for 12 weeks	New/Initiated
Pediatric NS Cohort	NS clinical program	Initiated assessment; expanding to Spain (up to three subjects)	Reported rapid improvement with whole-body dosing; no adverse events	Expanded/Positive update

No revenue, margin, OpEx, OI&E, tax rate or dividend guidance was issued in Q4 materials .

Earnings Call Themes & Trends

No Q4 2024 earnings call transcript was available; themes below reflect quarter press materials.

Topic	Previous Mentions (Q-2 and Q-1)	Current Period (Q4 2024)	Trend
Regulatory and trial execution	Planned international expansion (Saudi/EU) ; UK sites announced	FDA cleared whole-body QRX003 study	Positive acceleration
Clinical efficacy signals	—; expanding trials	Interim data show MIASI down 18→4; pruritus 7→4; IGA improved; pediatric improvement in 12 days; no AEs	Strengthening evidence
Pediatric program	Initiated assessment; plan for Spain cohort	Whole-body pediatric dosing shows transformational improvement, reduced concomitant meds; no AEs	Expanded scope/positive outcomes
Pipeline expansion	UCC partnership for topical rapamycin (microneedles)	Filed U.S./international patents for topical rapamycin formulations	Advancing IP and scope
Financial runway	Funding into late 2025	Runway extended to Q2 2026 following $6.8M offering	Improved liquidity
Geographic footprint	Planned UK/EU expansion	Confirmation of multi-site progress and Saudi site opening	Broader footprint

Management Commentary

“2024 was without a doubt the most significant year in Quoin’s history… The significant improvements observed across multiple clinical endpoints… provide further evidence of QRX003’s potential to address the underlying pathology of Netherton Syndrome.” — Michael Myers, CEO .
“Our recently announced FDA-cleared ‘whole-body’ clinical study… will become a central component of our regulatory approval submission.” — Michael Myers, CEO .
“Targeting kallikreins… could be an ideal approach.” — Dr. Amy Paller (Northwestern University), on mechanism underlying the whole-body study .

Q&A Highlights

No Q4 2024 earnings call transcript was found; therefore, no analyst Q&A highlights are available [ListDocuments: earnings-call-transcript returned 0].

Estimates Context

Wall Street consensus estimates via S&P Global for Q4 2024 could not be retrieved at this time; as such, comparisons to consensus EPS or revenue are unavailable. Values retrieved from S&P Global.*
As a late clinical-stage company, Quoin did not disclose quarterly revenue in its press materials, limiting margin and estimate-based comparisons .

Key Takeaways for Investors

Liquidity improved meaningfully: ~$14.1M in cash and investments and runway extended to Q2 2026 after the $6.8M offering; focus remains on clinical execution rather than near-term revenue generation .
Clinical derisking continues: FDA-cleared whole-body study and strong interim signals (MIASI, pruritus, IGA) with no AEs are supportive of QRX003’s mechanism and potential regulatory path .
Pediatric data and reduction in concomitant medications could be a compelling real-world efficacy narrative and patient-benefit driver .
Upcoming catalysts: initiation and data readouts from the whole-body study; progress in pediatric cohorts (Spain, UK), and broader site activation (Saudi Arabia) .
Risk remains concentrated in clinical outcomes and regulatory sufficiency; filings caution on recruitment, data robustness, and timelines—position sizing should reflect binary outcome paths .
With no revenue guidance and unavailable consensus estimates, trading setups may center on clinical newsflow; prepare for headline-driven volatility around study updates .
Medium-term thesis: continued pipeline expansion (topical rapamycin IP) and clinical momentum could create strategic optionality (partnering/M&A), while capital discipline and trial execution remain critical .

Quoin Pharmaceuticals, Ltd. (QNRX)·Q4 2024 Earnings Summary