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NewAmsterdam Pharma to Announce Topline Data from Pivotal Phase 3 BROOKLYN Clinical Trial Evaluating Obicetrapib in Patients with Heterozygous Familial Hypercholesterolemia on Monday, July 29, 2024
Newsfilter· 2024-07-26 20:01
Core Insights - NewAmsterdam Pharma is set to report topline data from its Phase 3 BROOKLYN clinical trial on July 29, 2024, focusing on oral, non-statin medicines for patients at risk of cardiovascular disease with elevated LDL-C levels [1][2] Company Overview - NewAmsterdam Pharma is a late-stage biopharmaceutical company dedicated to improving patient care in populations with metabolic diseases where existing therapies are inadequate or poorly tolerated [5] - The company is investigating obicetrapib, an oral, low-dose, once-daily CETP inhibitor, either alone or in combination with ezetimibe, as a therapy to lower LDL-C levels for patients at risk of cardiovascular disease [5]
NewAmsterdam Pharma Completes Enrollment in Pivotal Phase 3 TANDEM Clinical Trial Evaluating Fixed-Dose Combination of Obicetrapib plus Ezetimibe in Patients with HeFH and/or ASCVD or ASCVD Risk Factors
Newsfilter· 2024-07-08 12:00
Core Insights - NewAmsterdam Pharma has completed enrollment in the pivotal Phase 3 TANDEM trial, which is a significant milestone in the development of obicetrapib, a CETP inhibitor aimed at treating dyslipidemia [1][6] - The company is encouraged by positive enrollment trends in four ongoing pivotal Phase 3 studies, indicating strong interest from physicians and patients [1][2] - The TANDEM trial aims to evaluate the fixed-dose combination of obicetrapib and ezetimibe in patients with Heterozygous Familial Hypercholesterolemia (HeFH) and/or Atherosclerotic Cardiovascular Disease (ASCVD) [6][7] Company Overview - NewAmsterdam Pharma is a late-stage biopharmaceutical company focused on developing oral, non-statin therapies for patients at risk of cardiovascular disease with elevated LDL-C levels [3][10] - The company aims to address unmet needs for safe and well-tolerated LDL-lowering therapies [3] Clinical Trials - The TANDEM trial enrolled 407 patients with a baseline LDL-C of at least 70 mg/dL, evaluating the effect of a fixed-dose combination of obicetrapib and ezetimibe on LDL-C levels [7] - The trial's primary objective is to compare the LDL-C lowering effects of the combination therapy against monotherapy and placebo [7] - NewAmsterdam is also conducting two other pivotal Phase 3 trials, BROADWAY and BROOKLYN, to assess obicetrapib as a monotherapy and in combination with other lipid-lowering therapies [2][6] Market Potential - Cardiovascular disease remains a significant global health issue, with many patients unable to achieve target LDL-C levels despite existing therapies [2] - Obicetrapib has shown promise in previous Phase 2 trials, demonstrating statistically significant LDL-lowering effects with a side effect profile similar to placebo [2][6] - The company anticipates sharing topline data from the TANDEM study in the first quarter of 2025, which could influence its market positioning [1]
NewAmsterdam Pharma Completes Enrollment in Pivotal Phase 3 TANDEM Clinical Trial Evaluating Fixed-Dose Combination of Obicetrapib plus Ezetimibe in Patients with HeFH and/or ASCVD or ASCVD Risk Factors
GlobeNewswire News Room· 2024-07-08 12:00
Core Insights - NewAmsterdam Pharma has completed patient enrollment in the pivotal Phase 3 TANDEM clinical trial for obicetrapib plus ezetimibe, targeting patients with Heterozygous Familial Hypercholesterolemia (HeFH) and/or Atherosclerotic Cardiovascular Disease (ASCVD) [1][2] - The trial enrolled 407 patients with a baseline LDL-C of at least 70 mg/dL, aiming to evaluate the efficacy of the fixed-dose combination in lowering LDL-C levels compared to monotherapy and placebo [2][4] - The company anticipates sharing topline data from the TANDEM study in the first quarter of 2025, reflecting a positive trend in physician and patient interest in their clinical trials [2][3] Company Overview - NewAmsterdam Pharma is a late-stage biopharmaceutical company focused on developing oral, non-statin medicines for patients at risk of cardiovascular disease, particularly those with elevated LDL-C levels [1][5] - The company is conducting multiple Phase 3 trials, including BROADWAY, BROOKLYN, and PREVAIL, to assess the efficacy of obicetrapib as a monotherapy and in combination with ezetimibe [4][6] - Obicetrapib is a novel, low-dose CETP inhibitor designed to provide a safe and effective LDL-lowering therapy for patients who do not respond adequately to existing treatments [4][6]
NewAmsterdam Pharma to Present New Clinical and Preclinical Data Highlighting Obicetrapib's Impact on Key Risk Factors for Cardiovascular Disease at Upcoming Medical Meetings
Newsfilter· 2024-05-21 12:00
Core Insights - NewAmsterdam Pharma is presenting new clinical data on obicetrapib, a novel oral low-dose therapy for hypercholesterolemia, at upcoming scientific sessions in Europe and the U.S. [1][5] - The company is on track to report topline data from its Phase 3 BROOKLYN trial in HeFH in Q3 2024 and the BROADWAY trial in ASCVD in Q4 2024 [1] Clinical Trials and Presentations - NewAmsterdam will present findings from the OCEAN, ROSE, and ROSE2 Phase 2 clinical trials, showcasing obicetrapib's effects on lipid and lipoprotein biomarkers [1] - The EAS 92nd Congress will feature multiple presentations on obicetrapib, including its impact on HDL and Lp(a) levels, as well as its effects in combination with ezetimibe [2][3] - The NLA 2024 Scientific Sessions will also highlight obicetrapib's significant reductions in Lp(a) and its synergistic effects with ezetimibe [3][4] Product Development - Obicetrapib is being developed as a CETP inhibitor to address the limitations of current LDL-lowering treatments, with Phase 3 trials BROADWAY and BROOKLYN evaluating its efficacy as a monotherapy and in combination with other therapies [5][6] - The company has completed enrollment for the BROOKLYN and BROADWAY trials and is also conducting the PREVAIL trial to assess cardiovascular outcomes [5]
NewAmsterdam Pharma pany N.V.(NAMS) - 2024 Q1 - Quarterly Results
2024-05-09 12:00
NewAmsterdam Pharma Provides Corporate Update and Reports First Quarter Financial Results -- Enrolled over 9,500 patients in Phase 3 PREVAIL global CVOT-- -- On-track to report topline data from Phase 3 BROOKLYN trial in HeFH in 3Q 2024 and Phase 3 BROADWAY trial in ASCVD in 4Q 2024 -- -- Dosed first patients in TANDEM, pivotal Phase 3 trial evaluating fixed-dose combination of obicetrapib and ezetimibe; topline data expected in 1Q 2025 -- -- Company to host R&D event on May 16, 2024, beginning at 9:00 a.m. ...
NewAmsterdam Pharma pany N.V.(NAMS) - 2024 Q1 - Quarterly Report
2024-05-08 20:30
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, smaller reporting company, or an emerging growth company. See the de ...
NewAmsterdam Pharma pany N.V.(NAMS) - 2023 Q4 - Annual Results
2024-02-28 13:11
Exhibit 99.1 Naarden, the Netherlands and Miami, USA; February 28, 2024 – NewAmsterdam Pharma Company N.V. (Nasdaq: NAMS or "NewAmsterdam" or the "Company"), a late-stage, clinical biopharmaceutical company developing oral, non-statin medicines for patients at risk of cardiovascular disease with elevated low-density lipoprotein cholesterol ("LDL-C"), for whom existing therapies are not sufficiently effective or well-tolerated, today announced financial results for the fourth quarter and full year ended Dece ...
NewAmsterdam Pharma pany N.V.(NAMS) - 2023 Q4 - Annual Report
2024-02-28 13:00
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 FORM 10-K ☒ ANNUAL REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2023 OR ☐ TRANSITION REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _______ to _______ Commission File Number 001-41562 NewAmsterdam Pharma Company N.V. (Exact Name of Registrant as Specified in Its Charter) The Netherlands N/A (State or Other Jurisdiction ...
NewAmsterdam Pharma pany N.V.(NAMS) - 2023 Q2 - Quarterly Report
2023-08-07 11:24
Exhibit 99.1 (*) Restated - see Note 10 The accompanying notes are an integral part of these consolidated financial statements. CONDENSED CONSOLIDATED STATEMENTS OF PROFIT OR LOSS (UNAUDITED) CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE PROFIT OR LOSS (UNAUDITED) | | | For the six months ended June 30, | | | --- | --- | --- | --- | | | Note | 2023 | 2022 | | (In thousands of Euro, except per share amounts) | | | | | (Loss) / profit for the period | | (75,102 ) | 54,513 | | Items that may be reclassifi ...
NewAmsterdam Pharma pany N.V.(NAMS) - 2022 Q4 - Annual Report
2023-03-31 20:31
Revenue and Financial Performance - Revenue increased by €97.5 million, from nil for the year ended December 31, 2021 to €97.5 million for the year ended December 31, 2022, driven by the Menarini License upfront payment[605]. - The company reported a loss before tax of €78.1 million for the year ended December 31, 2022, compared to a loss of €28.6 million in 2021[604]. - Loss for the year increased by €49.5 million, from a loss of €28.6 million in 2021 to a loss of €78.1 million in 2022, mainly due to increased research and development expenses and share listing expenses[618]. - As of December 31, 2022, the company had an accumulated loss of €119.4 million and expects to continue incurring significant losses in the foreseeable future[620]. - Cash as of December 31, 2022, was €438.5 million, which is expected to fund operations through 2026 based on the current operating plan[622]. Expenses - Research and development expenses rose significantly to €82.2 million in 2022, up from €25.0 million in 2021, reflecting increased clinical trial activities[604]. - Selling, general and administrative expenses increased to €22.2 million in 2022 from €4.8 million in 2021, due to higher costs associated with being a public company[604]. - The total operating expenses for 2022 were €165.1 million, compared to €29.8 million in 2021, marking an increase of €135.2 million[604]. - Research and development expenses increased by €57.2 million, or 228%, from €25.0 million in 2021 to €82.2 million in 2022, primarily due to higher clinical trial costs[606]. - Selling, general and administrative expenses rose by €17.4 million, or 363%, from €4.8 million in 2021 to €22.2 million in 2022, driven by increased personnel and transaction costs[610]. - Share listing expenses amounted to €60.6 million in 2022, resulting from the Business Combination, reflecting the excess of the fair value of equity instruments issued over the fair value of net assets contributed[612]. Research and Development - Obicetrapib demonstrated a 51% median lowering of LDL-C from baseline at a 10 mg dose level in the Phase 2b ROSE trial[583]. - The company expects research and development expenses to increase substantially as it advances obicetrapib through clinical trials[595]. - The company has partnered with Menarini for the commercialization of obicetrapib in most European countries, pending marketing approval[585]. Foreign Currency and Risk Exposure - As of December 31, 2022, the company's net exposure to foreign currency risk was €268.2 million, up from €15.9 million as of December 31, 2021[602]. - The company recognized significant foreign exchange losses in 2022 due to holding a substantial U.S. Dollar balance while its functional currency is Euro[857]. - Net foreign exchange losses decreased by €10.7 million, from a gain of €1.4 million in 2021 to a loss of €9.3 million in 2022, primarily due to the appreciation of the U.S. Dollar[615]. - For the year ended December 31, 2022, the U.S. Dollar depreciation by 10% resulted in a loss of €24,361 thousand before tax, while a 10% appreciation led to a gain of €29,775 thousand[859]. Financing Activities - The company completed a Business Combination with FLAC, resulting in gross proceeds of $306.3 million from the transaction and associated PIPE Financing, after deducting $2.6 million in transaction costs[632]. - The PIPE Financing involved the issuance of 23,460,000 Ordinary Shares at $10.00 per share, generating gross proceeds of $234.6 million[631]. - The company reported net cash flows from financing activities of €375.2 million for the year ended December 31, 2022, compared to €69.0 million in 2021, reflecting the impact of the Business Combination[639]. Contractual Obligations and Liabilities - The company has estimated maximum contractual obligations of €16.6 million due within one year and €5.1 million due in more than a year related to third-party service agreements[640]. - As of December 31, 2022, derivative warrant liabilities amounted to €3.9 million and derivative earnout liability was €7.1 million[860]. - The company is responsible for 50% of certain development costs incurred by Menarini in the development of Licensed Products in the Menarini Territory[646]. - The company has not included potential cash proceeds from the exercise of Warrants in its liquidity projections, indicating uncertainty regarding their exercise[634]. Other Financial Information - For the year ended December 31, 2022, net cash provided by operating activities was €8.0 million, a significant improvement of €33.1 million compared to a net cash outflow of €25.2 million in 2021[635][636]. - A 15% increase in share price under derivative warrant liabilities (NAMSW) would decrease profit or loss before tax by €583 thousand, while a 15% decrease would increase it by the same amount[862]. - A 15% increase in share price under derivative earnout liability (NAMS) would decrease profit or loss before tax by €1,058 thousand, while a 15% decrease would increase it by the same amount[862]. - The company is exposed to credit risk primarily from treasury activities, with available cash held in banks with investment grade credit ratings[863]. - The CEO repaid a loan of €709 thousand on July 19, 2022, which was secured and bore interest[864]. - The company is currently engaged in research and development activities and does not have any sales, allowing it to reclaim recoverable Value Added Tax (VAT)[865].