NewAmsterdam Pharma Provides Corporate Update and Reports Second Quarter Financial Results
NewAmsterdam Pharma reported positive topline data from its Phase 3 BROOKLYN trial evaluating obicetrapib in patients with HeFH, achieving the primary endpoint of LDL-C reduction. The company extended US IP protection for obicetrapib into 2043 with a new composition of matter patent. Enrollment for the Phase 3 TANDEM trial evaluating a fixed-dose combination of obicetrapib and ezetimibe was completed, with topline data expected in Q1 2025. NewAmsterdam maintains a strong financial position with $430.7 million in cash. The company reported Q2 2024 financial results, including revenue of $2.3 million, R&D expenses of $38.4 million, and a net loss of $39.0 million. Upcoming milestones include topline data from the Phase 3 BROADWAY trial in Q4 2024.
NewAmsterdam Pharma ha riportato dati positivi di fase finale dalla sua analisi di fase 3 BROOKLYN che valuta obicetrapib in pazienti con HeFH, raggiungendo l'obiettivo primario di riduzione del LDL-C. L'azienda ha esteso la protezione della proprietà intellettuale negli USA per obicetrapib fino al 2043 con un nuovo brevetto sulla composizione. L'arruolamento per la fase 3 TANDEM che valuta una combinazione a dose fissa di obicetrapib ed ezetimibe è stato completato, con dati finali attesi per il primo trimestre del 2025. NewAmsterdam mantiene una solida posizione finanziaria con 430,7 milioni di dollari in contante. L'azienda ha riportato i risultati finanziari del secondo trimestre 2024, compresi ricavi di $2,3 milioni, spese di R&S di $38,4 milioni e una perdita netta di $39 milioni. Tra i prossimi traguardi ci sono i dati finali della fase 3 BROADWAY attesi per il quarto trimestre del 2024.
NewAmsterdam Pharma informó datos positivos preliminares de su ensayo de fase 3 BROOKLYN que evalúa obicetrapib en pacientes con HeFH, logrando el objetivo primario de reducción de LDL-C. La empresa extendió la protección de propiedad intelectual en EE. UU. para obicetrapib hasta 2043 con una nueva patente de materia. Se completó la inscripción para el ensayo de fase 3 TANDEM que evalúa una combinación de dosis fija de obicetrapib y ezetimibe, con datos preliminares esperados para el primer trimestre de 2025. NewAmsterdam mantiene una fuerte posición financiera con 430,7 millones de dólares en efectivo. La empresa informó de los resultados financieros del segundo trimestre de 2024, incluidos ingresos de 2,3 millones de dólares, gastos de I+D de 38,4 millones de dólares y una pérdida neta de 39 millones de dólares. Entre los próximos hitos se incluyen los datos preliminares del ensayo de fase 3 BROADWAY en el cuarto trimestre de 2024.
NewAmsterdam Pharma는 HeFH 환자를 대상으로 obicetrapib을 평가하는 3상 BROOKLYN 시험에서 긍정적인 최종 데이터를 보고하며 LDL-C 감소의 주요 목표를 달성했습니다. 이 회사는 새로운 물질 특허와 함께 obicetrapib에 대한 미국의 지적 재산 보호를 2043년까지 연장했습니다. obicetrapib과 ezetimibe의 고정 용량 복합제를 평가하는 3상 TANDEM 시험에 대한 등록이 완료되었으며, 최종 데이터는 2025년 1분기에 예상됩니다. NewAmsterdam은 4억 3천 70만 달러의 현금을 보유한 강력한 재무 위치를 유지하고 있습니다. 이 회사는 2024년 2분기 재무 결과를 보고했으며, 수익은 230만 달러, 연구개발비는 3840만 달러, 순손실은 3900만 달러입니다. 다가오는 이정표로는 2024년 4분기에 예정된 3상 BROADWAY 시험의 최종 데이터가 포함됩니다.
NewAmsterdam Pharma a rapporté des données positives préliminaires de son essai de phase 3 BROOKLYN évaluant l'obicetrapib chez des patients atteints d'HeFH, atteignant l'objectif principal de réduction du LDL-C. L'entreprise a étendu la protection de la propriété intellectuelle aux États-Unis pour l'obicetrapib jusqu'en 2043 grâce à un nouveau brevet sur la composition. L'inscription pour l'
NewAmsterdam Pharma hat positive Zwischenergebnisse aus seiner Phase 3 BROOKLYN-Studie veröffentlicht, die obicetrapib bei Patienten mit HeFH bewertet und den primären Endpunkt der LDL-C-Reduktion erreicht. Das Unternehmen hat den IP-Schutz für obicetrapib in den USA bis 2043 mit einem neuen Stoffpatent verlängert. Die Rekrutierung für die Phase 3 TANDEM-Studie, die eine Fixkombination aus obicetrapib und Ezetimib bewertet, wurde abgeschlossen, mit Zwischenergebnissen, die für das erste Quartal 2025 erwartet werden. NewAmsterdam hält eine starke finanzielle Position mit 430,7 Millionen Dollar in Bargeld. Das Unternehmen berichtete über die Finanzergebnisse für das 2. Quartal 2024, einschließlich Einnahmen von 2,3 Millionen Dollar, F&E-Ausgaben von 38,4 Millionen Dollar und einem Nett Verlust von 39 Millionen Dollar. Zu den bevorstehenden Meilensteinen gehören die Zwischenergebnisse der Phase 3 BROADWAY-Studie im 4. Quartal 2024.
- Positive topline data from Phase 3 BROOKLYN trial, achieving primary endpoint of LDL-C reduction
- Extended US IP protection for obicetrapib into 2043 with new composition of matter patent
- Completed enrollment for Phase 3 TANDEM trial
- Strong cash position of $430.7 million, up from $340.5 million in December 2023
- Revenue increased to $2.3 million in Q2 2024 from $1.7 million in Q2 2023
- Net loss increased to $39.0 million in Q2 2024 from $38.3 million in Q2 2023
- R&D expenses increased to $38.4 million in Q2 2024 from $34.3 million in Q2 2023
- SG&A expenses rose to $16.5 million in Q2 2024 from $9.9 million in Q2 2023
Insights
NewAmsterdam Pharma's Q2 results show strong financial positioning with
The positive topline data from the Phase 3 BROOKLYN trial is a significant milestone for NewAmsterdam. Obicetrapib demonstrated an impressive
The issuance of U.S. Patent No. 12,006,305 for obicetrapib's composition of matter is a crucial development for NewAmsterdam. This patent extends protection in the US until 2043, significantly strengthening the company's intellectual property position. The patent covers the specific solid form of obicetrapib to be used in the company's products, which will be listed in the FDA's "Orange Book" upon approval. This extended patent protection enhances the drug's commercial potential and provides a long runway for market exclusivity, potentially increasing the company's valuation and attractiveness to investors or potential acquirers.
-- Reported positive topline data from pivotal Phase 3 BROOKLYN trial evaluating obicetrapib in patients with HeFH; achieved primary endpoint of LS mean reduction in LDL-C versus placebo, as well as statistically significant reductions in other biomarkers, with safety results comparable to placebo –
-- Extended US IP protection into 2043 with a new composition of matter patent --
-- On-track to report topline data from pivotal Phase 3 BROADWAY trial in 4Q 2024 –
-- Completed enrollment of pivotal Phase 3 TANDEM trial evaluating fixed-dose combination of obicetrapib and ezetimibe; topline data expected in 1Q 2025 --
-- Strong financial position;
NAARDEN, the Netherlands and MIAMI, Aug. 07, 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 of 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 six months ended June 30, 2024.
“I am extremely pleased with our execution over the first half of 2024 and continue to be motivated by the team’s relentless commitment to unlocking the value of obicetrapib. We were thrilled to recently announce positive and statistically significant topline data from the pivotal Phase 3 BROOKLYN trial, which targeted heterozygous familial hypercholesterolemia (“HeFH”), a historically difficult-to-treat patient population, and underscores obicetrapib’s potential to address the significant unmet need for lipid lowering therapies,” said Michael Davidson, M.D., Chief Executive Officer of NewAmsterdam. “Results from BROOKLYN achieved LDL-C lowering consistent with our phase 2 studies, along with a safety profile comparable to placebo, and with over half of patients on obicetrapib achieving the LDL-C guideline directed treatment goal of less than 70 mg/dl, we believe obicetrapib has potential to improve patient care for those living with dyslipidemia.”
"In addition, we recently hosted an R&D Day event where we detailed the differentiated target product profile of obicetrapib, discussed our commercial strategy, and unveiled REMBRANDT, a Phase 3 clinical study evaluating the fixed-dose combination (“FDC”) of obicetrapib and ezetimibe on coronary atherosclerotic plaque buildup in adults with or at high risk of atherosclerotic cardiovascular disease (“ASCVD”),” Dr. Davidson continued. “Supported by our recently issued composition of matter patent, which extends patent protection in the US for obicetrapib into 2043, and
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.
- In July 2024, NewAmsterdam announced positive topline data from the Phase 3 BROOKLYN clinical trial evaluating obicetrapib in patients with HeFH.
- The BROOKLYN trial met its primary endpoint, with the obicetrapib arm achieving an LS mean reduction of
36.3% (p < 0.0001) compared to placebo at day 84, which was sustained at day 365 with an LS mean LDL-C reduction of41.5% (p < 0.0001). The observed changes in other biomarkers, including high-density lipoprotein cholesterol (“HDL-C”), non-HDL-C, lipoprotein(a) (“Lp(a)”), and apolipoprotein B (“ApoB”), met statistical significance and were consistent with data reported from the Company’s prior clinical trials. - In the trial, obicetrapib was observed to be well-tolerated, with safety results comparable to placebo and no increase in blood pressure, nor any difference from placebo in liver enzymes, hs-CRP, or renal function.
- NewAmsterdam plans to present full results from BROOKLYN at an upcoming medical conference and to publish the data in a major medical journal.
- The BROOKLYN trial met its primary endpoint, with the obicetrapib arm achieving an LS mean reduction of
- In July 2024, NewAmsterdam completed patient enrollment in the pivotal Phase 3 TANDEM clinical trial evaluating the FDC of obicetrapib plus ezetimibe in adult patients with HeFH and/or ASCVD or multiple risk factors for ASCVD.
- In May and June 2024, respectively, NewAmsterdam presented new clinical and preclinical data highlighting the potential for obicetrapib as a novel, oral, low-dose therapy for hypercholesterolemia, at the European Atherosclerosis Society (EAS) 92nd Congress and National Lipid Association (NLA) 2024 Scientific Sessions.
- In May 2024, NewAmsterdam announced the initiation of REMBRANDT, a Phase 3 clinical trial evaluating the FDC of obicetrapib and ezetimibe against placebo on coronary atherosclerotic plaque characteristics in adults with or at high-risk for ASCVD.
Corporate Updates
- In July 2024, NewAmsterdam appointed Mark C. McKenna and Wouter Joustra to its Board of Directors and announced the departure of Sander Slootweg from its Board of Directors.
- In June 2024, NewAmsterdam announced the United States Patent and Trademark Office (“USPTO”) issued U.S. Patent No. 12,006,305, titled “Salts of Obicetrapib and Processes for their Manufacture and Intermediates Thereof.” The patent contains claims covering amorphous obicetrapib hemicalcium, the solid form that will be used in the Company’s products and will be listed in the FDA’s “Orange Book” as a drug substance patent, if approved. The issuance of this composition of matter patent provides intellectual property protection for obicetrapib until July 2043.
- In May 2024, NewAmsterdam hosted an R&D Day event featuring presentations from Company management and key opinion leader cardiovascular disease specialists to discuss obicetrapib’s clinical development path, NewAmsterdam’s commercial readiness and strategy, and the cardiovascular disease landscape and opportunities for innovative new products. An archived replay of the event is available on the Investor Relations page of the NewAmsterdam website at ir.newamsterdampharma.com.
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 full data from Phase 3 BROOKLYN trial for obicetrapib monotherapy at an upcoming medical conference and publish the data in a major medical journal.
- 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 first quarter of 2025.
Second Quarter Financial Results
- Cash Position: As of June 30, 2024, NewAmsterdam recorded cash of
$430.7 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 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
$2.3 million in revenue for the three months ended June 30, 2024, compared to$1.7 million in the same period in 2023. This increase is due to an increase in the amount of previously deferred revenue which was recognized as revenue in the current period. - Research and Development (“R&D”) Expenses: R&D expenses were
$38.4 million for the three months ended June 30, 2024, compared to$34.3 million for the same period in 2023. This increase was primarily due to clinical expenses related to the Company’s ongoing Phase 3 clinical trials. - Selling, General and Administrative (“SG&A”) Expenses: SG&A expenses were
$16.5 million in three months ended June 30, 2024, compared to$9.9 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 June 30, 2024 was
$39.0 million , or$0.41 per diluted share, compared to net loss of$38.3 million , or$0.47 per diluted share, for the same period in 2023.
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 circumstances are beyond the control of the Company. These forward-looking statements are subject to a number of risks and uncertainties, including changes in domestic and foreign business, market, financial, political, and legal conditions; risks related to the approval of the Company’s product candidate and the timing of expected regulatory and business milestones, including potential commercialization; ability to negotiate definitive contractual arrangements with potential customers; the impact of competitive product candidates; ability to obtain sufficient supply of materials; global economic and political conditions, including the Russia-Ukraine and Israel-Hamas conflict; the effects of competition on the Company’s future business; and those factors described in the Company’s public filings with the Securities Exchange Commission. Additional risks related to the Company’s business include, but are not limited to: uncertainty regarding outcomes of the Company’s ongoing clinical trials, particularly as they relate to regulatory review and potential approval for its product candidate; risks associated with the Company’s efforts to commercialize a product candidate; the Company’s ability to negotiate and enter into definitive agreements on favorable terms, if at all; the impact of competing product candidates on the Company’s business; intellectual property related claims; the Company’s ability to attract and retain qualified personnel; ability to continue to source the raw materials for its product candidate. If any of these risks materialize or the Company’s assumptions prove incorrect, actual results could differ materially from the results implied by these forward-looking statements. There may be additional risks that the Company does not presently know or that the Company currently believes are immaterial that could also cause actual results to differ from those contained in the forward-looking statements. In addition, forward-looking statements reflect the Company’s expectations, plans, or forecasts of future events and views as of the date of this document and are qualified in their entirety by reference to the cautionary statements herein. The Company anticipates that subsequent events and developments may cause the Company’s assessments to change. These forward-looking statements should not be relied upon as representing the Company’s assessment as of any date subsequent to the date of this communication. Accordingly, undue reliance should not be placed upon the forward-looking statements. Neither the Company nor any of its affiliates undertakes any obligation to update these forward-looking statements, except as may be required by law.
Company Contact
Matthew Philippe
P: 1-917-882-7512
matthew.philippe@newamsterdampharma.com
Media Contact
Spectrum Science on behalf of NewAmsterdam
Bryan Blatstein
P: 1-917-714-2609
bblatstein@spectrumscience.com
Investor Contact
Precision AQ on behalf of NewAmsterdam
Austin Murtagh
P: 1-212-698-8696
austin.murtagh@precisionaq.com
Financial Tables
| NewAmsterdam Pharma Company N.V. Condensed Consolidated Balance Sheets (Unaudited) | |||||||
| June 30, 2024 | December 31, 2023 | ||||||
| (In thousands of USD) | |||||||
| Assets | |||||||
| Current assets: | |||||||
| Cash | 430,708 | 340,450 | |||||
| Prepayments and other receivables | 14,644 | 6,341 | |||||
| Total current assets | 445,352 | 346,791 | |||||
| Property, plant and equipment, net | 234 | 46 | |||||
| Operating right of use asset | 554 | 55 | |||||
| Intangible assets | 542 | 170 | |||||
| Long term prepaid expenses | 8 | 35 | |||||
| Total assets | 446,690 | 347,097 | |||||
| Liabilities and Shareholders' Equity | |||||||
| Current liabilities: | |||||||
| Accounts payable | 5,275 | 16,923 | |||||
| Accrued expenses and other current liabilities | 10,194 | 11,398 | |||||
| Deferred revenue, current | 6,059 | 8,942 | |||||
| Lease liability, current | 234 | 60 | |||||
| Derivative warrant liabilities | 23,545 | 12,574 | |||||
| Total current liabilities | 45,307 | 49,897 | |||||
| Deferred revenue, net of current portion | 222 | 1,019 | |||||
| Lease liability, net of current portion | 328 | - | |||||
| Derivative earnout liability | 13,394 | 7,788 | |||||
| Total liabilities | 59,251 | 58,704 | |||||
| Commitments and contingencies (Note 10) | |||||||
| Shareholders' Equity (deficit): | |||||||
| Ordinary shares, | 11,151 | 10,173 | |||||
| Additional paid-in capital | 821,613 | 590,771 | |||||
| Accumulated loss | (449,747 | ) | (316,973 | ) | |||
| Accumulated other comprehensive income | 4,422 | 4,422 | |||||
| Total shareholders' equity | 387,439 | 288,393 | |||||
| Total liabilities and shareholders' equity | 446,690 | 347,097 | |||||
| NewAmsterdam Pharma Company N.V. Condensed Consolidated Statements of Operations and Comprehensive Income (Loss) (Unaudited) | |||||||||||||||
| For the three months ended June 30, | For the six months ended June 30, | ||||||||||||||
| 2024 | 2023 | 2024 | 2023 | ||||||||||||
| (In thousands of USD, except per share amounts) | |||||||||||||||
| Revenue | 2,279 | 1,717 | 3,680 | 10,346 | |||||||||||
| Operating expenses: | |||||||||||||||
| Research and development expenses | 38,379 | 34,341 | 80,809 | 74,761 | |||||||||||
| Selling, general and administrative expenses | 16,475 | 9,858 | 30,928 | 17,920 | |||||||||||
| Total operating expenses | 54,854 | 44,199 | 111,737 | 92,681 | |||||||||||
| Operating loss | (52,575 | ) | (42,482 | ) | (108,057 | ) | (82,335 | ) | |||||||
| Other income (expense): | |||||||||||||||
| Interest income | 4,870 | 4,613 | 7,953 | 5,556 | |||||||||||
| Fair value change – earnout and warrants | 9,692 | (350 | ) | (29,258 | ) | (6,525 | ) | ||||||||
| Foreign exchange gains/(losses) | (994 | ) | (72 | ) | (3,412 | ) | 2,995 | ||||||||
| Loss before tax | (39,007 | ) | (38,291 | ) | (132,774 | ) | (80,309 | ) | |||||||
| Income tax expense | — | — | — | — | |||||||||||
| Loss and comprehensive loss for the period | (39,007 | ) | (38,291 | ) | (132,774 | ) | (80,309 | ) | |||||||
| Net loss per ordinary share | |||||||||||||||
| Basic and diluted | $ | (0.41 | ) | $ | (0.47 | ) | $ | (1.45 | ) | $ | (0.98 | ) | |||
| NewAmsterdam Pharma Company N.V. Condensed Consolidated Statements of Shareholders' Equity (Deficit) (Unaudited) | |||||||||||||||||||||||
| (In thousands of USD, except share amounts) | Shares | Amount | Additional Paid-In Capital | Accumulated Loss | Cumulative Translation Adjustments | Total Shareholders' Equity | |||||||||||||||||
| Balance at December 31, 2022 | 81,559,780 | 10,055 | 555,625 | (140,036 | ) | 4,422 | 430,066 | ||||||||||||||||
| Exercise of warrants | 208,032 | 27 | 2,671 | — | — | 2,698 | |||||||||||||||||
| Share-based compensation | — | — | 7,663 | — | — | 7,663 | |||||||||||||||||
| Total loss and comprehensive loss for the period | — | — | — | (42,018 | ) | — | (42,018 | ) | |||||||||||||||
| As at March 31, 2023 | 81,767,812 | 10,082 | 565,959 | (182,054 | ) | 4,422 | 398,409 | ||||||||||||||||
| Exercise of warrants | 541,609 | 70 | 7,444 | — | — | 7,514 | |||||||||||||||||
| Exercise of stock options | 14,910 | 2 | 103 | — | — | 105 | |||||||||||||||||
| Share-based compensation | — | — | 5,606 | — | — | 5,606 | |||||||||||||||||
| Total loss and comprehensive loss for the period | — | — | — | (38,291 | ) | — | (38,291 | ) | |||||||||||||||
| As at June 30, 2023 | 82,324,331 | 10,154 | 579,112 | (220,345 | ) | 4,422 | 373,343 | ||||||||||||||||
| Balance at December 31, 2023 | 82,469,768 | 10,173 | 590,771 | (316,973 | ) | 4,422 | 288,393 | ||||||||||||||||
| Issuance of Ordinary Shares and Pre-Funded Warrants, net of issuance costs | 5,871,909 | 759 | 189,207 | — | — | 189,966 | |||||||||||||||||
| Exercise of warrants | 926,698 | 121 | 19,674 | — | — | 19,795 | |||||||||||||||||
| Exercise of stock options | 452,461 | 60 | (609 | ) | — | — | (549 | ) | |||||||||||||||
| Share-based compensation | — | — | 7,965 | — | — | 7,965 | |||||||||||||||||
| Total loss and comprehensive loss for the period | — | — | — | (93,767 | ) | — | (93,767 | ) | |||||||||||||||
| As at March 31, 2024 | 89,720,836 | 11,113 | 807,008 | (410,740 | ) | 4,422 | 411,803 | ||||||||||||||||
| Exercise of warrants | 294,521 | 38 | 6,268 | — | — | 6,306 | |||||||||||||||||
| Share-based compensation | — | — | 8,337 | — | — | 8,337 | |||||||||||||||||
| Total loss and comprehensive loss for the period | — | — | — | (39,007 | ) | — | (39,007 | ) | |||||||||||||||
| As at June 30, 2024 | 90,015,357 | 11,151 | 821,613 | (449,747 | ) | 4,422 | 387,439 | ||||||||||||||||
| NewAmsterdam Pharma Company N.V. Condensed Consolidated Statements of Cash Flows (Unaudited) | |||||||
| For the six months ended June 30, | |||||||
| 2024 | 2023 | ||||||
| (In thousands of USD) | |||||||
| Operating activities: | |||||||
| Loss for the period | (132,774 | ) | (80,309 | ) | |||
| Non-cash adjustments to reconcile loss before tax to net cash flows: | |||||||
| Depreciation and amortization | 34 | 22 | |||||
| Non-cash rent expense | 3 | 3 | |||||
| Fair value change - derivative earnout and warrants | 29,258 | 6,525 | |||||
| Foreign exchange (gains)/losses | 3,412 | (2,995 | ) | ||||
| Share-based compensation | 16,208 | 13,174 | |||||
| Changes in working capital: | |||||||
| Changes in prepayments (current and non-current) and other receivables | (8,276 | ) | 4,038 | ||||
| Changes in accounts payable | (11,656 | ) | 1,410 | ||||
| Changes in accrued expenses and other current liabilities | (1,110 | ) | 1,925 | ||||
| Changes in deferred revenue | (3,680 | ) | (4,961 | ) | |||
| Net cash (used in)/provided by operating activities | (108,581 | ) | (61,168 | ) | |||
| Investing activities: | |||||||
| Purchase of property, plant and equipment, including internal use software | (594 | ) | (12 | ) | |||
| Net cash used in investing activities | (594 | ) | (12 | ) | |||
| Financing activities: | |||||||
| Proceeds from offering of Ordinary Shares and Pre-Funded Warrants | 190,481 | — | |||||
| Transaction costs on issue of Ordinary Shares and Pre-Funded Warrants | (515 | ) | — | ||||
| Proceeds from exercise of warrants | 13,421 | 8,621 | |||||
| Proceeds from exercise of options | 440 | 105 | |||||
| Payment of withholding taxes related to net share settlement of exercised options | (989 | ) | — | ||||
| Net cash provided by financing activities | 202,838 | 8,726 | |||||
| Net change in cash | 93,663 | (52,454 | ) | ||||
| Foreign exchange differences | (3,405 | ) | 1,432 | ||||
| Cash at the beginning of the period | 340,450 | 467,728 | |||||
| Cash at the end of the period | 430,708 | 416,706 | |||||
| Noncash financing and investing activities | |||||||
| Right-of-use assets obtained in exchange for new operating lease liabilities | 562 | — | |||||
FAQ
What were the key results of NewAmsterdam Pharma's (NAMS) Phase 3 BROOKLYN trial for obicetrapib?
When does NewAmsterdam Pharma (NAMS) expect to report topline data from the Phase 3 BROADWAY trial?
What was NewAmsterdam Pharma's (NAMS) cash position as of June 30, 2024?
What was NewAmsterdam Pharma's (NAMS) net loss for Q2 2024?
