NAMSW 最新10-Q变化

相对上期新增的文字 · 来源:10-Q · 2026-05-07

• Lowering of LDL-C has been associated with major adverse cardiovascular events (“MACE”) benefit in trials of LDL-C lowering drugs, including the REVEAL trial with the CETP inhibitor anacetrapib. In our Phase 3 BROADWAY clinical trial, we observed a 21% reduction in the exploratory MACE endpoint (cor…

• CVD is a leading cause of death worldwide. Atherosclerotic cardiovascular disease (“ASCVD”) is primarily caused by atherosclerosis, which involves the build-up of fatty material within the inner walls of the arteries. Atherosclerosis is the primary cause of heart attacks, strokes and peripheral vasc…

• important risk factors for ASCVD is hypercholesterolemia, which refers to elevated LDL-C levels within the body, commonly known as high cholesterol.

• We have partnered with A. Menarini International Licensing S.A. (“Menarini”), providing them with the exclusive rights to commercialize obicetrapib 10 mg, either as a sole active ingredient product or in a FDC with ezetimibe (the “Licensed Products”), in the majority of European countries (the Menar…

• Our current plan is to pursue development and, subject to the receipt of marketing approval, commercialization of obicetrapib in the United States ourselves, and to consider additional partners for jurisdictions outside of the United States and Europe, including in Japan and China. In addition to ou…

相对上期删除的文字 · 来源:10-Q · 2025-11-05

• Lowering of LDL-C, has been associated with major adverse cardiovascular events (“MACE”) benefit in trials of LDL-C lowering drugs, including the REVEAL trial with the CETP inhibitor, anacetrapib. In our Phase 3 BROADWAY clinical trial we observed a 21% reduction in the exploratory MACE endpoint (co…

• lipoprotein (“LDL”) particles and more specifically small LDL particles, which are believed to be more atherogenic particles.

• CVD is a leading cause of death worldwide. Atherosclerotic cardiovascular disease (“ASCVD”) is primarily caused by atherosclerosis, which involves the build-up of fatty material within the inner walls of the arteries. Atherosclerosis is the primary cause of heart attacks, strokes and peripheral vasc…

• We have partnered with A. Menarini International Licensing S.A. ("Menarini"), providing them with the exclusive rights to commercialize obicetrapib 10 mg, either as a sole active ingredient product or in a fixed-dose combination with ezetimibe, in the majority of European countries, if approved. Sub…

• Acceptance of Marketing Authorization Applications for Review by European Medicines Agency for Obicetrapib

相对上期新增的文字 · 来源:10-Q · 2026-05-07

• Foreign currency risk is the risk that the fair value or future cash flows of a financial instrument will fluctuate because of changes in foreign exchange rates. Our exposure to the risk of changes in foreign exchange rates relates primarily to cash and trade and other payables denominated in curren…

• U.S. Dollar. As of March 31, 2026, our net exposure to foreign currency risk was $80.9 million, mainly related to the Euro. As of March 31, 2026, the effect of a hypothetical 1% change in exchange rates on currencies denominated in other than our functional currency would result in a potential chang…

• As a result of the Business Combination, we have derivative warrant liabilities, which are measured at fair value through profit or loss. As at March 31, 2026 the fair value of the derivative warrant liabilities totaled $50.2 million. Prior to 2026, the fair value of the Warrants was determined usin…

相对上期删除的文字 · 来源:10-Q · 2025-11-05

• Foreign currency risk is the risk that the fair value or future cash flows of a financial instrument will fluctuate because of changes in foreign exchange rates. Our exposure to the risk of changes in foreign exchange rates relates primarily to cash and trade and other payables denominated in curren…

• As a result of the Business Combination, we have derivative warrant liabilities, which are measured at fair value through profit or loss. As of September 30, 2025 the fair value of the derivative warrant liabilities totaled $44.4 million. The value of the derivative warrant liability is directly cor…

相对上期新增的文字 · 来源:10-Q · 2026-05-07

• “Topline” and preliminary data or observed trends from our clinical trials that we announce or publish from time to time may change as more patient data become available and are subject to audit and verification procedures that could result in material changes in the final data.

• From time to time, we have disclosed and in the future may publicly disclose preliminary or “topline” data or observed trends from our clinical trials, which are based on a preliminary analysis of then-available data, and the results and related findings and conclusions are subject to change followi…

• For instance, we have conducted a preliminary review of blinded two-year data from our PREVAIL CVOT trial and have observed certain trends, including a Year 1 MACE event rate that is consistent with the event rate observed in BROADWAY and a greater than expected Year 1-to-Year 2 decline in MACE even…

• Further, others, including regulatory authorities and collaboration or regional partners, may not accept or agree with our assumptions, estimates, calculations, conclusions or analyses or may interpret or weigh the importance of data differently, which could impact the value of our particular progra…

• If the “topline” or preliminary data or observed trends that we report differ from actual results, or if others, including regulatory authorities, disagree with the conclusions reached, our ability to obtain approval for, and

相对上期删除的文字 · 来源:10-Q · 2025-11-05

• For example, in March 2010, President Obama signed into law the ACA, a law intended, among other things, to broaden access to health insurance, improve quality of care, and reduce or constrain the growth of healthcare spending. The ACA, among other things, imposed a new methodology by which rebates …

• Since its enactment, there have been numerous judicial, administrative, executive, and legislative challenges to certain aspects of the ACA. While Congress has not passed comprehensive repeal legislation, several bills affecting the implementation of certain taxes under the ACA have been signed into…

• significantly greater under the newly designed Part D benefit structure compared to the pre-IRA benefit design. Additionally, manufacturers that fail to comply with certain provisions of the IRA may be subject to penalties, including civil monetary penalties. The IRA is anticipated to have significa…

• In addition, other federal health reform measures have been proposed and adopted in the United States since the ACA was enacted. For example, as a result of the Budget Control Act of 2011, providers are subject to Medicare payment reductions of 2% per fiscal year, which went into effect on April 1, …

• Additionally, there has been heightened governmental scrutiny in the United States of pharmaceutical pricing practices in light of the rising cost of prescription drugs and biologics. Such scrutiny has resulted in several recent Congressional inquiries and proposed and enacted federal and state legi…

相对上期新增的文字 · 来源:10-Q · 2026-05-07

• On February 6, 2026, Ian Somaiya, our Chief Financial Officer terminated a Rule 10b5-1 trading arrangement intended to satisfy the affirmative defense of Rule 10b5-1(c) that he initially adopted on September 30, 2025 and that provided for the potential sale of up to 200,000 Ordinary Shares, subject …

• On February 27, 2026, Michael Davidson, our Chief Executive Officer, terminated a Rule 10b5-1 trading arrangement intended to satisfy the affirmative defense of Rule 10b5-1(c) that he initially adopted on September 29,

• 2025 and that provided for the potential sale of up to 750,000 Ordinary Shares, subject to certain price thresholds and other conditions. 306,293 Ordinary Shares were sold under this arrangement prior to its termination.

• Other than as discussed above, during the three months ended March 31, 2026, none of our directors or officers (as defined in Rule 16a-1(f) promulgated under the Exchange Act) adopted or terminated a Rule 10b5-1 trading arrangement (as defined in Item 408(a)(1)(i) of Regulation S-K) or a non-10b5-1 …

相对上期删除的文字 · 来源:10-Q · 2025-11-05

• Except as set forth below, during the three months ended September 30, 2025, none of our officers or directors adopted, amended or terminated a “Rule 10b5-1 trading arrangement,” as defined in Item 408(c) of Regulation S-K, each of which is intended to satisfy the affirmative defense of Rule 10b5-1(…

• On September 26, 2025, Michael Davidson, our Chief Executive Officer, terminated a Rule 10b5-1 trading arrangement that he initially adopted on March 10, 2025, and modified on June 30, 2025, and replaced it with a new Rule 10b5-1 trading arrangement adopted on September 29, 2025 providing for the po…

• On September 29, 2025, Douglas Kling, our Chief Operating Officer, adopted a Rule 10b5-1 trading arrangement for the potential sale of up to 594,573 Ordinary Shares, subject to certain price thresholds and other conditions. The arrangement's expiration date is December 31, 2026.

• Except as set forth below, no officer or director adopted, amended or terminated a “non-Rule 10b5-1 trading arrangement,” as defined in Item 408(c) of Regulation S-K, during the three months ended September 30, 2025.

• In September 2025, each holder of outstanding restricted stock units (including each of our officers) entered into a Sell-to-Cover Agreement that constitute a "non-Rule 10b5-1 trading arrangement," which provides for the pre-arranged sale of a portion of any Ordinary Shares deliverable to such holde…