NAMS — what changed in the latest 10-Q

Text added vs the prior filing · source: 10-Q · 2026-08-05

• with respect to the Year 1-to-Year 2 period discussed above). Additionally, the Year 1 and Year 1-to-Year 2 MACE event trends observed to date may not be indicative of future trends.

• considered constrained at contract execution and was not initially recognized within the transaction price until it became highly probable of no significant revenue reversal. Both annual development cost contributions have since been recognized within the transaction price.

• Revenue was $3.7 million for the three months ended June 30, 2026 compared to $19.1 million for the three months ended June 30, 2025, a decrease of $15.4 million, or 81%. This decrease is largely due to the recognition of $16.1 million of revenue in the comparative period related to the second insta…

• an $11.1 million increase in clinical expenses mainly due to the initiation of clinical trials and increased costs associated with the progression of ongoing trials, as well as credits received upon the close-out of trials in the comparative period that did not recur in the current period;

• a $3.3 million increase in personnel expenses related to research and development activities, including the impact of including medical affairs related personnel costs in the current period, as discussed above. The remainder of the change is primarily driven by increased recruitment and employment c…

Text removed vs the prior filing · source: 10-Q · 2026-05-07

• Comparison of the three months ended March 31, 2026 and 2025

• Revenue was $3.0 million for the three months ended March 31, 2026 compared to $3.0 million for the three months ended March 31, 2025. Revenue for the three months ended March 31, 2025 was due to recognition of deferred revenue related to the R&D performance obligation. Revenue for the three months …

• a $8.3 million decrease in clinical expenses primarily due to the completion of Phase 3 clinical trials in the first half of 2025;

• a $2.9 million decrease in non-clinical expenses primarily due to reduced activity related to pipeline expansion and product lifecycle management;

• a $2.7 million increase in personnel expenses related to research and development activities, including the impact of including medical affairs related personnel costs in the current period, as discussed above. The remainder of the change is primarily driven by increased recruitment and employment c…

Text added vs the prior filing · source: 10-Q · 2026-08-05

• 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…

• We partly manage our foreign currency risk by selectively holding foreign currency in our cash to offset foreign currency exposures from trade and other payables. We plan to use this cash to settle future expenses we expect to incur in those foreign currencies.

• As a result of the Business Combination, we have derivative warrant liabilities, which are measured at fair value through profit or loss. As of June 30, 2026 the fair value of the derivative warrant liabilities totaled $54.5 million. Prior to 2026, the fair value of the Warrants was determined using…

Text removed vs the prior filing · source: 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…

• We partly manage our foreign currency risk by selectively holding foreign currency in our cash to offset foreign currency exposures from lease liabilities and trade and other payables. We plan to use this cash to settle future expenses we expect to incur in those foreign currencies.

• 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…

Text added vs the prior filing · source: 10-Q · 2026-08-05

• controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate.

Text added vs the prior filing · source: 10-Q · 2026-08-05

• business prospects. Further, disclosure of interim data or results of interim analyses by us or by our competitors could result in volatility in the price of our Ordinary Shares.

• For example, we expect to conduct an interim analysis of our Phase 3 PREVAIL CVOT in the fourth quarter of 2026. The interim analysis will be conducted by the DSMB for the trial and will remain blinded to us. Based on certain pre-specified criteria that we have set, as well as other considerations f…

• For example, the IRA sets forth meaningful changes to drug product reimbursement by Medicare. The IRA, among other things, (i) directs HHS to negotiate the price of certain high-expenditure, single-source drugs and biologics covered under Medicare, and subjects drug manufacturers to civil monetary p…

• The IRA permits HHS to engage in price-capped negotiation to set the price of certain drugs and biologics reimbursed under Medicare Part B and Part D. The IRA contains statutory exclusions to the Negotiation Program, including for certain orphan-designated drugs for which the only approved indicatio…

• penalties. The IRA is anticipated to have significant effects on the pharmaceutical industry and may reduce the prices we can charge and reimbursement we can receive for our products, among other effects.

Text removed vs the prior filing · source: 10-Q · 2026-05-07

• commercialize, obicetrapib may be harmed, which could significantly harm our business, financial condition, results of operations and prospects.

• For example, we expect to conduct an interim analysis of our Phase 3 PREVAIL CVOT in the fourth quarter of 2026. The interim analysis will be conducted by the DSMB for the trial and will remain blinded to us. Based on certain pre-specified criteria that we have set, as well as other considerations f…

• For example, the IRA sets forth meaningful changes to drug product reimbursement by Medicare. The IRA, among other things, (i) directs HHS to negotiate the price of certain high-expenditure, single-source drugs and biologics covered under Medicare, and subjects drug manufacturers to civil monetary p…

• effective in 2028, and 20 Part B or Part D drugs, effective in 2029 and each year thereafter. This provision applies to drug products that have been approved for at least 7 years and biologics that have been licensed for 11 years, but it does not apply to drugs and biologics that have been approved …

• The IRA permits HHS to engage in price-capped negotiation to set the price of certain drugs and biologics reimbursed under Medicare Part B and Part D. The IRA contains statutory exclusions to the negotiation program, including for certain orphan-designated drugs for which the only approved indicatio…

Text added vs the prior filing · source: 10-Q · 2026-08-05

• During the three months ended June 30, 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 trading arrangement (as defined …

Text removed vs the prior filing · source: 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 23, 2026, Louise Kooij, our Chief Accounting Officer, adopted a Rule 10b5-1 trading arrangement intended to satisfy the affirmative defense of Rule 10b5-1(c) providing for the potential sale of up to 210,000 Ordinary Shares, subject to certain price thresholds and other conditions. The a…

• 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.

• On March 31, 2026, Futurum B.V., an entity affiliated with John Kastelein, our Chief Scientific Officer, adopted a Rule 10b5-1 trading arrangement intended to satisfy the affirmative defense of Rule 10b5-1(c) providing for the potential sale of up to 250,000 Ordinary Shares, subject to certain price…