MLTX — what changed in the latest 10-Q

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

• These forward-looking statements are subject to a number of important risks, uncertainties and other factors that could cause actual results to differ materially from those in the forward-looking statements expressed or implied in this Quarterly Report. Such risks, uncertainties and other factors in…

• •securities litigation following periods of volatility in the marketplace or our share price; and

• •the ability to adequately protect our intellectual property rights; and

• •the other factors described under the caption “Risk Factors” in our Annual Report, as may be updated in this Quarterly Report, and our other filings with the Securities and Exchange Commission (the “SEC”).

• multivalent molecules with enhanced ability to penetrate inflamed tissue, especially when containing an additional albumin binding domain such as SLK, an easier manufacturing process and a higher thermostability.

Text removed vs the prior filing · source: 10-Q · 2025-11-05

• •litigation and the ability to adequately protect our intellectual property rights; and

• •the other factors described under the caption “Risk Factors” in our Annual Report, as may be updated in this Quarterly Report on Form 10-Q, and our other filings with the Securities and Exchange Commission (the “SEC”).

• 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. In October 20…

• 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. In March 2024, we announced positi…

• In March 2024, we announced plans to initiate clinical studies of SLK in additional indications, including a Phase 3 trial in adolescent patients with HS (the VELA-TEEN trial (M1095-HS-304)), a Phase 2 trial in patients with PPP (the LEDA trial (M1095-PPP-201)), a Phase 2 trial in patients with axSp…

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

• As of March 31, 2026, our management, under the supervision and with the participation of our Chief Executive Officer and Chief Financial Officer, has evaluated the effectiveness of the design and operation of our disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) of the…

• 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 removed vs the prior filing · source: 10-Q · 2025-11-05

• including our Chief Executive Officer and Chief Financial Officer, as appropriate, to allow timely decisions regarding required disclosures.

• As of September 30, 2025, our management, under the supervision and with the participation of our Chief Executive Officer and Chief Financial Officer, has evaluated the effectiveness of the design and operation of our disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) of…

• 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 September 30, 2025 that have materially affected, or are reasonably likely to mat…

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

• From time to time, we may become involved in legal proceedings arising in the ordinary course of our business. Regardless of outcome, litigation can have an adverse impact on us due to defense and settlement costs, diversion of management resources, negative publicity, reputational harm and other fa…

• On October 15, 2025, a lawsuit captioned Bridgewood v. MoonLake Immunotherapeutics, et al., Case No. 1:25-cv-8500 (the “Bridgewood Action”) was filed in the United States District Court for the Southern District of New York, naming the Company, its Chief Executive Officer, and its Chief Financial Of…

• 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 removed vs the prior filing · source: 10-Q · 2025-11-05

• On October 15, 2025, a lawsuit captioned Bridgewood v. MoonLake Immunotherapeutics, et al., Case No. 1:25-cv-8500 (the “Bridgewood Action”) was filed in the United States District Court for the Southern District of New York, naming the Company, its Chief Executive Officer, and its Chief Financial Of…

• 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. …

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

• Geopolitical events and global economic conditions, such as public health crises, the conflicts between Russia and Ukraine and in the Middle East, could seriously and adversely affect our preclinical studies and ongoing and anticipated clinical trials, business, financial condition and results of op…

• 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 …

• Geopolitical events and global economic conditions may also affect the ability of the FDA, EMA, and other regulatory authorities to perform routine functions. If such concerns prevent the FDA, EMA, or other regulatory authorities from conducting their regular inspections, reviews or other regulatory…

Text added 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…

• During the three months ended March 31, 2026, no other director or Section 16 officer of the Company adopted or terminated any “Rule 10b5-1 trading arrangement” or “non-Rule 10b5-1 trading arrangement”, as each term is defined in Item 408(a) of Regulation S-K.

Text removed vs the prior filing · source: 10-Q · 2025-11-05

• None of our directors or executive officers adopted or terminated a Rule 10b5-1 trading arrangement or a non-Rule 10b5-1 trading arrangement during the three months ended September 30, 2025, as such terms are defined under Item 408(a) of Regulation S-K.