NewAmsterdam Pharma Provides Corporate Update and Reports First Quarter Financial Results

-- EMA submission expected in 2H25 by partner Menarini --

-- PREVAIL Phase 3 CVOT remains on track --

-- BROADWAY and TANDEM results presented at EAS with simultaneous publications in the New England Journal of Medicine and The Lancet, respectively --

-- Company to host R&D day on June 11(th) , 2025 in New York City --

--$808.5 million in cash, cash equivalents and marketable securities at March 31, 2025 --

NAARDEN, The Netherlands and MIAMI, May 08, 2025 (GLOBE NEWSWIRE) -- NewAmsterdam Pharma Company N.V. (Nasdaq: NAMS or "NewAmsterdam," "we," or the "Company"), a late-stage, clinical biopharmaceutical company developing oral, non-statin medicines for patients at risk of cardiovascular disease ("CVD") 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 quarter ended March 31, 2025 and provided a corporate update.

"Our first quarter was marked by continued clinical execution and investment in our commercial organization to support the potential launch of obicetrapib," said Michael Davidson, M.D., Chief Executive Officer of NewAmsterdam. "With over $800 million in cash, cash equivalents and marketable securities on our balance sheet, we believe we are well positioned to drive near- and long-term value for our stakeholders, as we move closer to delivering novel, once-daily, low dose, oral therapies to address the significant global unmet need for safe and effective LDL-C lowering therapies."

Dr. Davidson continued, "In addition, the data recently presented at EAS and published in the New England Journal of Medicine and The Lancet highlight obicetrapib's differentiated product profile for the potential treatment of lipid management, and we are eager to continue to share additional data from our three pivotal Phase 3 trials, particularly regarding obicetrapib's impact on major adverse cardiac events ("MACE"), at prominent medical conferences and journal publications. We are also progressing with regulatory interactions, including an expected EMA submission in the second half of the year by our partner Menarini. This commercial and clinical progress, combined with our financial strength provides a foundation for future growth as we look to address the needs of many more patients living with dyslipidemia."

Clinical Development Updates

NewAmsterdam is developing obicetrapib, an oral, low-dose, once-daily, highly-selective cholesteryl ester transfer protein ("CETP") inhibitor, as the preferred LDL-C lowering therapy to be used in patients at risk of CVD for whom existing therapies are not sufficiently effective or well-tolerated. Additional data from BROADWAY, TANDEM, and BROOKLYN is expected to be presented and published over the next several months, highlighting what we believe to be obicetrapib's differentiated product profile to lipid management.

Ongoing Trials:

Following the successful completion of the Phase 3 BROADWAY, TANDEM, and BROOKLYN trials NewAmsterdam plans to announce additional data over the course of 2025 relating to obicetrapib and the fixed-dose combination ("FDC") of obicetrapib plus ezetimibe.

The following trials are currently ongoing:

   -- PREVAIL Phase 3 trial. PREVAIL is a cardiovascular outcomes trial 
      ("CVOT") evaluating obicetrapib in patients with a history of 
      atherosclerotic cardiovascular disease ("ASCVD"), whose LDL-C is not 
      adequately controlled despite being on maximally tolerated lipid-lowering 
      therapy. NewAmsterdam completed enrollment of over 9,500 patients in 
      April 2024. 
 
   -- VINCENT Phase 2 trial. The trial will evaluate the effects of obicetrapib 
      alone and in combination with evolocumab on lipoprotein (a) ("Lp(a)") in 
      patients with mild dyslipidemia. The single arm study will treat patients 
      with obicetrapib 10 mg daily for 8 weeks followed by obicetrapib 10 mg 
      daily plus evolocumab 140 mg/dL every other week for 8 weeks. There will 
      be two cohorts in the study. The first cohort will include 39 
      participants with Lp(a) levels greater than 125 nmol/L, and the second 
      cohort will include 30 participants with Lp(a) levels greater than 50 
      nmol/L but less than 125 nmol/L. 
 
   -- REMBRANDT Phase 3 trial. The trial will utilize coronary computed 
      tomography angiography imaging to evaluate the effect of obicetrapib plus 
      ezetimibe FDC on coronary plaque. The placebo-controlled, double-blind, 
      randomized, Phase 3 trial is being conducted in adult participants with 
      high-risk ASCVD with evidence of coronary plaque who are not adequately 
      controlled by their maximally tolerated lipid-modifying therapy, to 
      assess the impact of the obicetrapib 10 mg plus ezetimibe 10 mg FDC daily 
      on coronary plaque and inflammation characteristics. The study is 
      expected to enroll 300 patients. 

Corporate Updates

   -- In April 2025, NewAmsterdam appointed Adele Gulfo to the Company's Board 
      of Directors. Ms. Gulfo is an established pharmaceutical executive with 
      over three decades of experience in the healthcare industry, 
      distinguished by her expertise in global strategy, operations leadership, 
      and commercialization of multiple blockbuster medicines. 

Upcoming Investor Event

NewAmsterdam will host an R&D Day event on Wednesday, June 11, 2025, beginning at 9 a.m. ET in New York City.

A live webcast of the event will be available through the investor relations section of the NewAmsterdam website at ir.newamsterdampharma.com. Following the live webcast, an archived replay will be available on the Company's website.

First Quarter Financial Results

   -- Cash Position: As of March 31, 2025, NewAmsterdam recorded cash, cash 
      equivalents and marketable securities of $808.5 million, compared to 
      $834.2 million as of December 31, 2024. The decrease is primarily driven 
      by ongoing operating expenditures, partially offset by the first of two 
      development cost contributions from our partner Menarini and cash 
      received from interest and the exercise of options. 
 
   -- Revenue: NewAmsterdam recognized $3.0 million in revenue for the quarter 
      ended March 31, 2025, compared to $1.4 million in the same period in 
      2024. The increase is primarily attributable to the increase in 
      transaction price attributable to the R&D performance obligation as a 
      result of the recognition in 2024 of the first of two annual development 
      cost contributions pursuant to the terms of the license agreement with 
      Menarini. 
 
   -- Research and Development ("R&D") Expenses: R&D expenses were $44.8 
      million in the quarter ended March 31, 2025, compared to $42.4 million 
      for the same period in 2024. This increase was primarily due to an 
      increase in personnel costs, including share-based compensation, 
      non-clinical costs related to pipeline expansion and product lifecycle 
      management and investments in commercial manufacturing capabilities, 
      partially offset by a decrease in clinical expenses. 
 
   -- Selling, General and Administrative ("SG&A") Expenses: SG&A expenses were 
      $27.2 million in the quarter ended March 31, 2025, compared to $14.5 
      million for the same period in 2024. This increase was primarily due to 
      an increase in personnel costs, including share-based compensation, and 
      investments in capabilities to support the Company's planned commercial 
      launch of obicetrapib, if approved and an increase in costs related to 
      the Company's intellectual property primarily driven by worldwide patent 
      filings. 
 
   -- Net loss: Net loss for the quarter ended March 31, 2025 was $39.5 million, 
      compared to net loss of $93.8 million for the same period in 2024. The 
      individual components of the change are described above in addition to 
      non-cash losses related to changes in the fair value of our derivative 
      liabilities. 

About Obicetrapib

Obicetrapib is a novel, oral, low-dose CETP inhibitor that NewAmsterdam is developing to overcome the limitations of current LDL-lowering treatments. In each of the Company's Phase 2 trials, ROSE2, TULIP, ROSE, and OCEAN, as well as the Company's Phase 3 BROOKLYN, BROADWAY and TANDEM trials, evaluating obicetrapib as monotherapy or combination therapy, the Company observed statistically significant LDL-lowering combined with a side effect profile similar to that of placebo. The Company commenced the Phase 3 PREVAIL CVOT in March 2022, which is designed to assess the potential of obicetrapib to reduce occurrences of MACE. The Company completed enrollment of PREVAIL in April 2024 and randomized over 9,500 patients. Commercialization rights of obicetrapib in Europe, either as a monotherapy or as part of a fixed-dose combination with ezetimibe, have been exclusively granted to the Menarini Group, an Italy-based, leading international pharmaceutical and diagnostics company.

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