NewAmsterdam Pharma pany N.V.(NAMS)

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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].
NewAmsterdam Pharma pany N.V.(NAMS) - 2022 Q4 - Annual Report
2023-03-31 12:36
[Full Year 2022 Financial Results and Corporate Update](index=1&type=section&id=Full%20Year%202022%20Financial%20Results%20and%20Corporate%20Update) NewAmsterdam Pharma reported its 2022 financial results, detailing significant corporate and clinical advancements for obicetrapib and a strong cash position [Corporate and Clinical Highlights](index=1&type=section&id=Corporate%20and%20Clinical%20Highlights) NewAmsterdam Pharma achieved key 2022 milestones, including a successful business combination, a **$235 million** PIPE financing, and positive ROSE2 Phase 2 trial results - Completed a business combination with FLAC and a concurrent, oversubscribed PIPE financing of approximately **$235 million**, which is expected to fund operations through 2026[1](index=1&type=chunk) - Announced positive topline results from the ROSE2 Phase 2 clinical trial, which evaluated obicetrapib in combination with ezetimibe[1](index=1&type=chunk) - Advanced three pivotal Phase 3 trials (BROOKLYN, BROADWAY, and PREVAIL) and initiated a Phase 2 dose-finding study in Japanese patients[1](index=1&type=chunk)[3](index=3&type=chunk) [Clinical Pipeline Updates](index=1&type=section&id=Clinical%20Pipeline%20Updates) Obicetrapib is advancing through three pivotal Phase 3 trials, with the ROSE2 Phase 2 trial showing a **59% LDL-C reduction** and good tolerability - The ROSE2 Phase 2 trial met its primary endpoint, with the combination of obicetrapib and ezetimibe achieving a median LDL-C reduction of **59%** compared to 6% for placebo (p<0.0001)[4](index=4&type=chunk) - The combination of obicetrapib and ezetimibe was observed to be well-tolerated, with a safety profile comparable to placebo[4](index=4&type=chunk) - Three pivotal Phase 3 trials are ongoing: BROOKLYN (for HeFH), BROADWAY (for ASCVD), and PREVAIL (a cardiovascular outcomes trial)[4](index=4&type=chunk) - A Phase 2 dose-finding study of obicetrapib was initiated in 108 Japanese patients with dyslipidemia in October 2022[5](index=5&type=chunk) [Corporate Highlights](index=2&type=section&id=Corporate%20Highlights) NewAmsterdam completed its business combination with Frazier Lifesciences Acquisition Corporation (FLAC) in November 2022, raising **$328 million** gross proceeds, including a **$235 million** PIPE financing - Completed a business combination with FLAC in November 2022, yielding gross proceeds of approximately **$328 million** before expenses[8](index=8&type=chunk) - The transaction included approximately **$93 million** from the FLAC trust account and a **$235 million** oversubscribed PIPE financing co-led by Frazier Healthcare Partners and Bain Capital Life Sciences[8](index=8&type=chunk) - Appointed John W Smither to the Board of Directors and as chair of the Audit Committee in February 2023[8](index=8&type=chunk) [Upcoming Potential Milestones](index=2&type=section&id=Upcoming%20Potential%20Milestones) Key upcoming milestones include full ROSE2 data in **June 2023**, Phase 3 trial enrollment completion by **mid-2023**, and Japanese Phase 2 results in **H2 2023** - **June 2023**: Present full data from the Phase 2 ROSE2 trial[7](index=7&type=chunk) - **H2 2023**: Select a formulation for a fixed-dose combination of obicetrapib and ezetimibe[7](index=7&type=chunk) - **Mid-2023**: Complete enrollment for Phase 3 BROOKLYN and BROADWAY trials[7](index=7&type=chunk) - **H2 2024**: Announce topline data from BROOKLYN and BROADWAY trials[7](index=7&type=chunk) - **H2 2023**: Announce topline results from the Phase 2 study in Japanese patients and the Phase 2a Alzheimer's biomarker study[7](index=7&type=chunk) - **H2 2023**: Complete enrollment for the Phase 3 PREVAIL trial, with topline data expected in **H2 2026**[7](index=7&type=chunk) [Full Year 2022 Financial Results](index=2&type=section&id=Full%20Year%202022%20Financial%20Results) NewAmsterdam's 2022 financials show a cash increase to **€439 million**, **€98 million** revenue, and a **€78 million** net loss due to higher R&D and transaction costs Full Year 2022 Financial Highlights (in millions of Euro) | Metric | FY 2022 | FY 2021 | Change | Reason for Change | | :--- | :--- | :--- | :--- | :--- | | **Cash Position** | €439M | €53M | +€386M | Menarini upfront payment and business combination proceeds | | **Revenue** | €98M | €0M | +€98M | Portion of upfront payment from Menarini license agreement | | **R&D Expenses** | €82M | €25M | +€57M | Increased costs for ongoing obicetrapib clinical trials | | **SG&A Expenses** | €22M | €5M | +€17M | Increased personnel, legal, and transaction costs | | **Net Loss** | €78M | €29M | +€49M | Higher operating expenses and share listing costs | | **Net Loss Per Share** | €(0.96) | €(1.19) | Improved | N/A | [Financial Guidance](index=3&type=section&id=Financial%20Guidance) NewAmsterdam expects its **€439 million** cash position to fund operations through 2026, extending beyond its three ongoing Phase 3 trial data readouts - The company believes its existing cash of **€439 million** will fund operations through 2026[9](index=9&type=chunk)[8](index=8&type=chunk) - This financial runway is expected to last beyond the completion and data readouts of the three ongoing Phase 3 trials (BROADWAY, BROOKLYN, and PREVAIL)[9](index=9&type=chunk) [Consolidated Financial Statements](index=5&type=section&id=Consolidated%20Financial%20Statements) The consolidated financial statements detail NewAmsterdam's significant asset and equity growth in 2022, alongside increased liabilities and a net loss [Consolidated Statements of Financial Position](index=5&type=section&id=Consolidated%20Statements%20of%20Financial%20Position) As of December 31, 2022, total assets increased to **€531.6 million** and equity to **€484.5 million**, driven by cash from financing and licensing Statement of Financial Position (in thousands of Euro) | Account | Dec 31, 2022 | Dec 31, 2021 | | :--- | :--- | :--- | | **Total Assets** | **€531,583** | **€59,782** | | Cash | €438,522 | €53,092 | | Intangible assets | €83,160 | €0 | | **Total Liabilities** | **€47,062** | **€9,991** | | Deferred revenue (Current & Non-current) | €17,500 | €0 | | **Total Equity** | **€484,521** | **€49,791** | [Consolidated Statements of Profit or Loss and Comprehensive Loss](index=6&type=section&id=Consolidated%20Statements%20of%20Profit%20or%20Loss%20and%20Comprehensive%20Loss) For 2022, the company reported **€97.5 million** revenue but a **€78.1 million** net loss, primarily due to increased operating expenses and a **€60.6 million** share listing expense Statement of Profit or Loss (in thousands of Euro) | Account | 2022 | 2021 | | :--- | :--- | :--- | | Revenue | €97,500 | €0 | | Research and development expenses | (€82,230) | (€25,032) | | Selling, general and administrative expenses | (€22,230) | (€4,803) | | Share listing expense | (€60,600) | €0 | | **Operating loss** | **(€67,560)** | **(€29,835)** | | **Loss for the year** | **(€78,052)** | **(€28,599)** | | **Basic and diluted loss per share** | **€(0.96)** | **€(1.19)** |