SKINVISIBLE, INC.
SKVI evidence brief
What we can confirm
- BioSniper Score:
- 5.1 / 10
- Market Cap:
- $1.1M
- Lead Asset:
- procort (Approved)
What it means
What to watch
Prepared research question
What matters most for SKVI—catalysts, financial risk and supporting evidence?
Traceable citations · Unknowns marked
BioSniper AI · SKVI
SKINVISIBLE, INC. (SKVI) is a pre-revenue biotechnology company that licenses its Invisicare drug-delivery technology to partners, with its lead program — QRX003 for Netherton Syndrome — being developed by licensee Quoin Pharmaceuticals and holding FDA Fast Track, Orphan Drug, and Pediatric Rare Disease designations.
Key risk: No revenue and negative equity
BioSniper Score
Based on 3 of 6 signals
Limited data coverage
Market Cap
$1.1M
Cash Runway
—
Lead Asset
procort (Approved)
Next Catalyst
—
Financial data as of Jun 30, 2026.
Tracking 1 pipeline candidate for SKINVISIBLE, INC..
SKINVISIBLE, INC. (SKVI) is a pre-revenue biotechnology company that licenses its Invisicare drug-delivery technology to partners, with its lead program — QRX003 for Netherton Syndrome — being developed by licensee Quoin Pharmaceuticals and holding FDA Fast Track, Orphan Drug, and Pediatric Rare Disease designations.
- SKINVISIBLE reported total revenue of $0.0M and a net loss of -$0.3M for the period ending 2026-06-30, with negative shareholders' equity of -$10.8M [sec].
- The company's licensee, Quoin Pharmaceuticals, has received FDA Fast Track Designation, Orphan Drug Designation, and Pediatric Rare Disease Designation for QRX003 in Netherton Syndrome [sec_mda · as of 2026-08-13].
- SKINVISIBLE is entitled to a $5 million milestone payment upon first FDA or EU regulatory approval of a licensed product, plus a single-digit royalty on net sales and 25% of any sublicensing royalties [sec_mda · as of 2026-08-13].
- Clinical data from Quoin's studies showed 'significant clinical improvements' with disease classification improving from 'severe' to 'mild' after 6 weeks, and no adverse events reported [sec_mda · as of 2026-08-13].
- The FDA indicated that a single Phase 3 study may be sufficient for marketing approval of QRX003, and expressed openness to an alternative trial design such as randomized withdrawal or delayed start [sec_mda · as of 2026-08-13].
What works
- QRX003 has received multiple FDA designations (Fast Track, Orphan Drug, Pediatric Rare Disease) and EMA Orphan Drug Designation, which can accelerate development and provide market exclusivity [sec_mda · as of 2026-08-13].
- The FDA's openness to a single Phase 3 study and alternative trial design reduces the regulatory burden and potential cost of the pivotal program [sec_mda · as of 2026-08-13].
- SKINVISIBLE has a structured licensing deal with Quoin that includes a $5 million milestone payment upon first regulatory approval, ongoing royalties, and a share of sublicensing revenue, providing a clear monetization path [sec_mda · as of 2026-08-13].
What to weigh
- SKINVISIBLE has no current product revenue and reported a net loss of -$0.3M with negative shareholders' equity of -$10.8M as of 2026-06-30, indicating a reliance on partner milestones and future royalties [sec].
- The company's financial health is entirely dependent on Quoin's success in advancing QRX003 through Phase 3 and obtaining regulatory approval, which carries clinical and regulatory risk [sec_mda · as of 2026-08-13].
- The $5 million milestone payment is contingent on the first FDA or EU approval of a licensed product, which has not yet occurred and has no guaranteed timeline [sec_mda · as of 2026-08-13].
From the filings
Quoted directly from source documents.
SKINVISIBLE's licensee Quoin has obtained FDA Fast Track Designation for QRX003.
“FDA Grants Fast Track Designation for QRX003 for the Treatment of Netherton Syndrome”
SEC MD&A · August 13, 2026
SKINVISIBLE is entitled to a $5 million milestone payment upon first FDA or EU approval.
“the agreement also requires that Quoin make a milestone payment of $5 million to us upon achieving the first to occur of either FDA or European Union regulatory approval for one product licensed”
SEC MD&A · August 13, 2026
FDA indicated a single Phase 3 study may be sufficient for approval.
“FDA indicated that a single Phase 3 study may be sufficient to support marketing approval for QRX003 for Netherton Syndrome”
SEC MD&A · August 13, 2026
Risks & what to watch (3)›
Key risks
- No revenue and negative equity — As of 2026-06-30, SKINVISIBLE had $0.0M revenue, -$0.3M net loss, and -$10.8M shareholders' equity, indicating financial strain [sec].
- Single-partner dependency — All near-term value depends on Quoin's Phase 3 success and regulatory approval of QRX003, with no diversified pipeline [sec_mda · as of 2026-08-13].
- Milestone payment uncertain — The $5 million milestone is contingent on first FDA or EU approval, which has no set date and may be delayed or not occur [sec_mda · as of 2026-08-13].
What to watch
- Initiation and results of the pivotal Phase 3 study for QRX003, which the FDA indicated may be a single study [sec_mda · as of 2026-08-13].
- Any FDA or EU regulatory approval decision for QRX003, which would trigger the $5 million milestone payment to SKINVISIBLE [sec_mda · as of 2026-08-13].
- Updates on Quoin's clinical data from ongoing Phase 2 and pediatric studies, which will support the Phase 3 package [sec_mda · as of 2026-08-13].
- SKINVISIBLE's financial position and any changes in cash runway or accumulated deficit in future SEC filings [sec].
Sources: SEC MD&A · Generated October 13, 2026 · How we verify sources →
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Evidence & data
Score breakdownBased on 3 of 6 signals · derived from public data
Cash runway data unavailable
Net income -$256K
Lead: Approved
1 candidate
No upcoming catalysts tracked
No insider transactions in the last 180 days
Pipeline
Financials
Governance
Frequently asked questions
What is the AI investment thesis for SKINVISIBLE, INC.?
SKINVISIBLE, INC. (SKVI) is a pre-revenue biotechnology company that licenses its Invisicare drug-delivery technology to partners, with its lead program — QRX003 for Netherton Syndrome — being developed by licensee Quoin Pharmaceuticals and holding FDA Fast Track, Orphan Drug, and Pediatric Rare Disease designations.
What is SKINVISIBLE, INC.'s lead drug candidate?
SKINVISIBLE, INC.'s most advanced tracked candidate is procort (Approved) for Hemorrhoids.
Who is the CEO of SKINVISIBLE, INC.?
Mr. Terry H. Howlett is the chief executive officer of SKINVISIBLE, INC. (SKVI).
Where is SKINVISIBLE, INC. headquartered?
SKINVISIBLE, INC. (SKVI) is headquartered in Las Vegas, NV, United States.
The AI overview and BioSniper Score are neutral, data-derived signals built from public SEC filings, ClinicalTrials.gov and FDA records — not investment advice.