MLTX — what changed in the latest 10-Q

Text added vs the prior filing · source: 10-Q · 2026-08-10

• In June 2026, we announced the week 52 results of the VELA-1 trial (M1095-HS-301) and VELA-2 trial (M1095-HS-302), marking the end of the parental trial time period. Week 52 data for SLK showed consistent and further improvement in all clinical scores, compared to week 16 data. Across VELA-1 and VEL…

• In June 2026, we presented an interim analysis of the VELA-TEEN clinical trial (M1095-HS-304) based on the latest available data. The data showed rapid onset and high response rates in adolescent patients with HS. At week 24, ~68% of patients treated with SLK achieved HiSCR75, alongside ~86% achievi…

• The VELA trials are followed by an open-label extension for up to two years (the VELA-OLE trial (M1095-HS-303)).

• The comparisons above to results reported in other sponsors' clinical programs, and between our own trials, are not based on head-to-head studies. Differences in trial design, patient populations, endpoints, analysis methods, timing and trial conduct may materially affect the comparability of these …

• In August 2026, we announced positive results from an analysis of the week 16 primary endpoint in the IZAR-1 trial (M1095-PSA-301) which met all clinical endpoints at week 16 for 60 mg SLK. 42.1% of biologic-naïve patients treated with SLK 60 mg with induction achieved an American College of Rheumat…

Text removed vs the prior filing · source: 10-Q · 2026-05-11

• In May 2022, we initiated a Phase 2b trial of SLK in patients with moderate-to-severe HS (the MIRA trial (M1095-HS-201)), and in June 2023, we announced positive top-line results from this trial, which met its primary endpoint of Hidradenitis Suppurativa Clinical Response (“HiSCR”) 75 with 43% of pa…

• In November 2025, we were granted a Type B meeting with the FDA to discuss adequacy of the current clinical evidence package of SLK in HS to support a Biologics License Application (“BLA”) and in January 2026, we announced positive feedback from this interaction, confirming that we may establish sub…

• In April 2026, we conducted a positive pre-BLA meeting with the FDA which constituted the last expected meeting with the FDA before the anticipated filing of the BLA for SLK in HS. In the meeting, we confirmed key elements of the proposed BLA submission package. No gaps were identified and we expect…

• In December 2022, we initiated a Phase 2b trial in patients with active PsA (the ARGO trial (M1095-PSA-201)) and in November 2023, we announced positive top-line results from this trial, which met its primary endpoint of American College of Rheumatology (“ACR”) 50 with 46% of patients on 60mg SLK ac…

• In November 2024, we initiated a Phase 2 trial in patients with PPP (the LEDA trial (M1095-PPP-201)) and in November 2025, we presented positive results of this trial, suggesting that SLK could provide clinically meaningful improvements in patients with PPP. Patients treated with SLK achieved a mean…

Text added vs the prior filing · source: 10-Q · 2026-08-10

• In May 2026, we implemented a new enterprise resource planning (“ERP”) system, impacting our finance and procurement processes. As a result of the ERP system implementation, certain internal controls over financial reporting have been automated, modified, or newly designed to address the new control…

• Except as noted above, there were no changes in our internal control over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) of the Exchange Act) during the three months ended June 30, 2026 that have materially affected, or are reasonably likely to materially affect, our internal contr…

Text removed vs the prior filing · source: 10-Q · 2026-05-11

• There were no changes in our internal control over financial reporting (as defined in Rules 13a-15(e) and 15d-15(e) of the Securities Exchange Act of 1934, as amended, or the Exchange Act) during the three months ended March 31, 2026 that have materially affected, or are reasonably likely to materia…

Text added vs the prior filing · source: 10-Q · 2026-08-10

• On January 6, 2026, the Court appointed lead plaintiff and lead counsel. On April 16, 2026, lead plaintiff filed an amended complaint naming the Company, its Chief Executive Officer, its Chief Financial Officer, and its Chief Scientific Officer as defendants. The amended complaint covers the same Cl…

Text removed vs the prior filing · source: 10-Q · 2026-05-11

• On October 17, 2025, a second putative class action captioned Peters v. MoonLake Immunotherapeutics, et al., Case No. 1:25-cv-8612 (the “Peters Action” and, together with the Bridgewood Action, the “Class Actions”) was filed in the United States District Court for the Southern District of New York (…

• On April 16, 2026, lead plaintiff filed an amended complaint naming the Company, its Chief Executive Officer, its Chief Financial Officer, and its Chief Scientific Officer as defendants. The amended complaint covers the same Class Period and asserts substantially similar claims under the Exchange Ac…

Text added vs the prior filing · source: 10-Q · 2026-08-10

• As a result of global economic conditions, including new or increased tariffs imposed by the United States government and potential retaliatory measures by foreign governments and other barriers to trade, especially in light of recent executive orders made by the presidential administration, trade a…

• Other potential disruptions include but are not limited to: delays or difficulties in enrolling patients in, initiating or expanding our clinical trials, including delays or difficulties with clinical site initiation and recruiting clinical site investigators and clinical site staff; increased rates…

Text removed vs the prior filing · source: 10-Q · 2026-05-11

• As a result of global economic conditions, including new or increased tariffs imposed by the U.S. government and potential retaliatory measures by foreign governments and other barriers to trade, especially in light of recent executive orders made by the presidential administration, trade and other …

Text added vs the prior filing · source: 10-Q · 2026-08-10

• On August 3, 2026, the Company entered into a Second Amendment to Loan and Security Agreement (the "Second Amendment") with Hercules Capital, Inc., as administrative and collateral agent, and the lenders party thereto, amending the Loan and Security Agreement. The Second Amendment, among other thing…

• A copy of the Second Amendment is filed as Exhibit 10.4 and is incorporated herein by reference. The foregoing description of the Second Amendment does not purport to be complete and is qualified in its entirety by reference to such exhibit.

Text removed vs the prior filing · source: 10-Q · 2026-05-11

• On March 10, 2026, Dr. Kristian Reich, the Chief Scientific Officer of the Company, adopted a trading plan intended to satisfy the affirmative defense of Rule 10b-1(c). Dr. Reich's plan provides for the sale, subject to certain conditions, of up to 450,000 Class A Ordinary Shares through November 24…

• On March 31, 2026, Dr. Jorge Santos da Silva, the Chief Executive Officer and a director of the Company, adopted a trading plan intended to satisfy the affirmative defense of Rule 10b-1(c). Dr. Santos da Silva's plan provides for the sale, subject to certain conditions, of up to 150,000 Class A Ordi…