NewAmsterdam Pharma Provides Corporate Update and Reports Third Quarter Financial Results

-- Topline data from pivotal Phase 3 TANDEM trial now expected in 4Q 2024 due to faster than expected enrollment --

-- On-track to report topline data from pivotal Phase 3 BROADWAY trial in 4Q 2024 --

-- Strong balance sheet with $422.7 million in cash as of September 30, 2024 --

NAARDEN, The Netherlands and MIAMI, Nov. 06, 2024 (GLOBE NEWSWIRE) -- 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 ("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 three and nine months ended September 30, 2024.

"We are pleased to report another strong quarter, which was marked by continued execution across our ongoing Phase 3 clinical trials. We are excited to announce that due to faster than expected enrollment in our pivotal Phase 3 TANDEM trial evaluating a fixed-dose combination ("FDC") of obicetrapib and ezetimibe, we now expect to release topline data in the fourth quarter of 2024," said Michael Davidson, M.D., Chief Executive Officer of NewAmsterdam. "Additionally, we remain on track to announce topline data from our Phase 3 BROADWAY study by year end and continue to advance our 9,500-patient PREVAIL cardiovascular outcomes trial."

"We believe there is a substantial opportunity to address the unmet needs across cardiovascular disease, one of the leading causes of mortality worldwide. With our recently secured composition of matter patent granting exclusivity through 2043 in the United States, cash which we believe is sufficient to fund our pivotal Phase 3 readouts, and an experienced leadership team at the helm, we are well-positioned to drive our mission forward. We remain focused on our clinical execution and, if approved, ultimately commercializing obicetrapib to transform patient care for the millions of people living with hyperlipidemia," continued Dr. Davidson.

Clinical Development Updates

NewAmsterdam is developing obicetrapib, an oral, low-dose and once-daily 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.

   -- Due to faster than expected patient enrollment in the pivotal Phase 3 
      TANDEM trial evaluating the obicetrapib and ezetimibe FDC, in patients 
      with heterozygous familial hypercholesterolemia ("HeFH") and/or 
      atherosclerotic cardiovascular disease ("ASCVD") or ASCVD risk 
      equivalents, the Company expects to announce topline data in the fourth 
      quarter of 2024. 

Upcoming Potential Milestones

NewAmsterdam's global, pivotal Phase 3 clinical development program consists of four studies in over 12,250 patients, three for obicetrapib monotherapy and one for a FDC of obicetrapib and ezetimibe. NewAmsterdam currently expects to achieve the following upcoming milestones:

   -- Announce additional safety and efficacy data from the Phase 3 BROOKLYN 
      trial for obicetrapib monotherapy at the upcoming 2024 AHA Scientific 
      Sessions taking place November 16 -- 18 in Chicago, Illinois. 
 
   -- Announce topline data from the Phase 3 BROADWAY trial for obicetrapib 
      monotherapy in the fourth quarter of 2024. BROADWAY is evaluating 
      obicetrapib in adult patients with HeFH and/or established ASCVD, whose 
      LDL-C is not adequately controlled, despite being on maximally tolerated 
      lipid-lowering therapy. 
 
   -- Announce topline data from the Phase 3 TANDEM trial evaluating a FDC of 
      obicetrapib and ezetimibe in the fourth quarter of 2024. 

Third Quarter Financial Results

   -- Cash Position: As of September 30, 2024, NewAmsterdam recorded cash of 
      $422.7 million, compared to $340.5 million as of December 31, 2023. The 
      increase in cash is primarily driven by the proceeds of the follow-on 
      offering conducted earlier this year, the achievement of a clinical 
      development milestone and warrant exercises partially offset by cash 
      outflows related to research and development costs as the Company 
      continues development of obicetrapib and increased spending on selling, 
      general and administrative expenses to support the Company's growing 
      organization. 
 
   -- Revenue: NewAmsterdam recognized $29.1 million in revenue for the three 
      months ended September 30, 2024, compared to $2.9 million in the same 
      period in 2023. This increase is primarily due to the achievement of a 
      clinical development milestone from Menarini during the current period. 
 
   -- Research and Development ("R&D") Expenses: R&D expenses were $35.7 
      million for the three months ended September 30, 2024, compared to $43.4 
      million for the same period in 2023. This decrease was primarily due to a 
      decrease in clinical expenses related to clinical trials which are 
      completed or nearing completion. 
 
   -- Selling, General and Administrative ("SG&A") Expenses: SG&A expenses were 
      $18.4 million in three months ended September 30, 2024, compared to $9.1 
      million for the same period in 2023. This increase was primarily due to 
      an increase in personnel costs related to expansion of the team to 
      support the growth of the organization and investments in capabilities to 
      support the Company's planned commercial launch of obicetrapib, if 
      approved. 
 
   -- Net loss: Net loss for the three months ended September 30, 2024 was 
      $16.6 million compared to net loss of $47.1 million for the same period 
      in 2023. The individual components of the change are described above. 

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 trial, 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 is conducting an additional Phase 3 pivotal trial BROADWAY, to evaluate obicetrapib as a monotherapy used as an adjunct to maximally tolerated lipid-lowering therapies to provide additional LDL-lowering for CVD patients, and TANDEM, to evaluate obicetrapib and ezetimibe as a fixed-dose combination. The Company began enrolling patients in BROADWAY in January 2022 and in TANDEM in March 2024; completing enrollment of BROADWAY in July 2023, and TANDEM in July 2024. The Company also commenced the Phase 3 PREVAIL cardiovascular outcomes trial in March 2022, which is designed to assess the potential of obicetrapib to reduce occurrences of major adverse cardiovascular events, including cardiovascular death, non-fatal myocardial infarction, non-fatal stroke and non-elective coronary revascularization. NewAmsterdam 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, for cardiovascular diseases have been exclusively granted to the Menarini Group, an Italy-based, leading international pharmaceutical and diagnostics company.

About NewAmsterdam

NewAmsterdam Pharma (Nasdaq: NAMS) is a late-stage biopharmaceutical company whose mission is to improve patient care in populations with metabolic diseases where currently approved therapies have not been adequate or well tolerated. We seek to fill a significant unmet need for a safe, well-tolerated and convenient LDL-lowering therapy. In multiple phase 3 studies, NewAmsterdam is investigating obicetrapib, an oral, low-dose and once-daily CETP inhibitor, alone or as a fixed-dose combination with ezetimibe, as LDL-C lowering therapies to be used as an adjunct to statin therapy for patients at risk of CVD with elevated LDL-C, for whom existing therapies are not sufficiently effective or well tolerated.

Forward-Looking Statements

Certain statements included in this document that are not historical facts are forward-looking statements for purposes of the safe harbor provisions under the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements generally are accompanied by words such as "believe," "may," "will," "estimate," "continue," "anticipate," "intend," "expect," "should," "would," "plan," "predict," "potential," "seem," "seek," "future," "outlook" and similar expressions that predict or indicate future events or trends or that are not statements of historical matters. These forward-looking statements include, but are not limited to, statements regarding the Company's intellectual property and its ability to enforce, and sufficiency of, its patents, the Company's business and strategic plans, the Company's commercial opportunity, the therapeutic and curative potential of the Company's product candidate, the Company's clinical trials and the timing for enrolling patients, the timing and forums for announcing data, the achievement and timing of regulatory approvals, and plans for commercialization. These statements are based on various assumptions, whether or not identified in this document, and on the current expectations of the Company's management and are not predictions of actual performance. These forward-looking statements are provided for illustrative purposes only and are not intended to serve as and must not be relied on as a guarantee, an assurance, a prediction, or a definitive statement of fact or probability. Actual events and circumstances are difficult or impossible to predict and may differ from assumptions. Many actual events and

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