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MoonLake Immunotherapeutics

MLTX Rare disease Lead: NDA Submitted 3 Biotech Distilled articles ↓ 22 filings & releases ↓ Cash $380M (Sep 30, 2026) ↓ 3 verdicts ↓ 6 timing quotes ↓
DermatologyImmunology Protein

Market cap $981M 85.1M shares (10-Q, Nov 1, 2026) × $11.53 close Nov 6, 2026

Most recent annual filing: 2026-02-25

Catalyst timeline

9 trackedQuarter catalyst calendar →
  1. Sonelokimab PPP Ph3 startNov 2026Sonelokimab PPP Ph3 start, Nov 2026, routine
  2. NOVA corporate updateNov 2026NOVA corporate update, Nov 2026, routine
  3. Sonelokimab HS PDUFA dateDec 2026Sonelokimab HS PDUFA date, Dec 2026, thesis-defining
  4. Sonelokimab PsA topline1Q 2027Sonelokimab PsA topline, 1Q 2027, material
  5. Sonelokimab HS topline1Q 2027Sonelokimab HS topline, 1Q 2027, material
  6. Sonelokimab axSpA interimEnd 2026 / early 2027Sonelokimab axSpA interim, End 2026 / early 2027, notable
  7. Sonelokimab PsA readout1H 2027Sonelokimab PsA readout, 1H 2027, notable
  8. Hercules Loan Tranche 3 corporateMar 15, 2027Hercules Loan Tranche 3 corporate, Mar 15, 2027, routine
  9. Sonelokimab HS commercial launch2H 2027Sonelokimab HS commercial launch, 2H 2027, routine

Bar width shows how precise the guidance is — a pin is a stated date, a wide band a six-month window. Deeper blue means more of the thesis rides on the event; it is not a view on the stock.

Pipeline (4 active programs)

Technology platforms

Nanobody · Ablynx

Nanobody platform — antibody-derived VHH-based targeted therapies enabling multivalent constructs with small size, enhanced tissue penetration, and bespoke target combinations; applied across inflammatory diseases including hidradenitis suppurativa, psoriatic arthritis, axial spondyloarthritis, and palmoplantar pustulosis.

Targets: IL-17A, IL-17F

Capital (as filed)

Cash
$380M cash and cash equivalents · Sep 30, 2026 (10-Q)
Short-term investments
$119M Sep 30, 2026
Operating cash flow
−$63.4M quarter Jun 30, 2026 → Sep 30, 2026, year-to-date difference (10-Q)
As stated in coverage
$499M cash, runway mid-2028 per the update of Nov 4, 2026 — the company's own words as read there, not the filed figure

Offering documents (1)

Cash, investments and operating cash flow are the company's own XBRL facts as filed with the SEC, each shown with its period end and tag. As-stated figures come from the company's own words as read in Biotech Distilled coverage, dated, and routinely count securities and planned financing that a balance sheet does not. Offering rows are the SEC cover pages as filed. Not investment advice. Figures as of Nov 7, 2026.

Biotech Distilled coverage (3)

Articles open on Substack. Some are subscriber-only; those marked ★ Distilled Pro are for Distilled Pro members.

Verdict history (3 calls)

Every verdict Biotech Distilled has published on MoonLake Immunotherapeutics, oldest first — the full history, never a selection. How calls are scored: the track record.

  1. 2026-08-11 Watch MoonLake Immunotherapeutics (MLTX) — Scientific Deep Dive for Sonelokimab and Pipeline Products Sonelokimab's efficacy differentiation rests on denominator choices and a set-aside trial; the de-risking event is the Section 14 label content at BLA acceptance in late November 2026.
  2. 2026-08-12 Watch UPDATE: MoonLake Immunotherapeutics (MLTX) - A Phase 3 Win That Nobody Bought IZAR-1 Phase 3 win is positive but pre-priced; the de-risking event remains the Section 14 label content at BLA acceptance in late November 2026, with IZAR-2 in Q4 as the second key print.
  3. 2026-11-05 Watch UPDATE: MoonLake Immunotherapeutics (MLTX) - The Tranche Lapsed, the Readout Slipped Tranche 4 lapsed and IZAR-2 slipped to Q1 2027, worsening the clock, but valuation improved materially; the real de-risking event (HS label efficacy table content) has moved to 2027.

Every verdict Biotech Distilled has published on this company, in order, with the post it came from — the full history, never a selection. Position figures are the same ones shown on /track-record, computed by the same method. Editorial opinion, not investment advice.

Timing, in the company's words (6 quotes from 3 filings)

Sentences quoted verbatim from the company's SEC filings, newest filing first. Each sits under the filing it appeared in; the "matched to" tag names the calendar row it was read for.

Timing sentences quoted from the company's own SEC filings, each under the filing it appeared in. The 'matched to' tag is the calendar row the sentence was read for; the filing is the source. Not investment advice.

Filings & releases (22)

SEC filings from EDGAR and press releases captured from the company's investor-relations site, newest first. Releases captured from Aug 10, 2026; filings from March 2026. Summaries come from the BD update that read the document; "BD extracted" counts point at the pipeline table above. All companies →

6 more filings (13G holder notices, S-8, proxy material, SEC correspondence …)