— Announced full data from ROSE2 Phase 2 clinical trial evaluating combination of obicetrapib and ezetimibe, which met the primary endpoint with 63.4% median reduction in LDL-C (p<0.0001) —
— Announced topline results from Phase 2b dose-finding trial evaluating obicetrapib in Japanese patients, which met the primary endpoint with 45.8% median reduction in LDL-C (p < 0.0001) in patients treated with 10mg obicetrapib monotherapy —
— Closed $182 million up-sized and oversubscribed secondary offering, expanding shareholder base with strong participation from new investors, existing shareholders, and insiders —
— Completed enrollment in BROADWAY Phase 3 clinical trial evaluating obicetrapib in patients with HeFH and/or established ASCVD, exceeding enrollment target —
— Topline data from Phase 3 BROOKLYN and BROADWAY trials on-track to be announced in 2H 2024–
NAARDEN, The Netherlands and MIAMI, Aug. 07, 2023 (GLOBE NEWSWIRE) — NewAmsterdam Pharma Company N.V. (Nasdaq: NAMS or “NewAmsterdam” or the “Company”), a clinical-stage biopharmaceutical company developing oral, non-statin medicines for patients at high risk of cardiovascular disease (“CVD”) with residual elevation of low-density lipoprotein cholesterol (“LDL-C” or “LDL”), for whom existing therapies are not sufficiently effective or well-tolerated, today provided a corporate update and announced financial highlights for the quarter ended June 30, 2023.
“The second quarter and recent months were marked by tremendous progress across our organization,” said Michael Davidson, M.D., Chief Executive Officer of NewAmsterdam. “In June, we announced full data from the ROSE2 Phase 2 clinical trial evaluating the combination of obicetrapib and ezetimibe, as well as topline results from the Phase 2b dose-finding trial evaluating obicetrapib in Japanese patients. Both studies met their primary endpoints, achieving statistically significant and clinically meaningful reductions in LDL-C, as well as improvements in additional lipid and lipoprotein parameters that we believe are predictive of cardiovascular disease risk. With these results in-hand, we have now completed five Phase 2 trials of obicetrapib as a monotherapy or combination agent, where we have consistently observed the benefit and a well-tolerated safety profile, and supporting our belief that obicetrapib could meaningfully change the care and treatment of hypercholesterolemia and other cardiometabolic diseases.”
Dr. Davidson continued, “Our attention is now focused on advancing our pivotal Phase 3 program, which includes the ongoing BROADWAY, BROOKLYN and PREVAIL trials. In July, we announced the over enrollment of BROADWAY, just months after we completed enrollment in BROOKLYN, reinforcing our belief in the robust demand for a convenient, oral therapy that can augment high-intensity statin therapy and enable many more patients to reach their risk-based LDL-C goals. We look forward to sharing topline data from BROADWAY and BROOKLYN in the second half of 2024, as we work to establish obicetrapib as a next-generation CETP inhibitor for some of the world’s most prevalent and debilitating diseases.”
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 as an adjunct to maximally tolerated statin therapy for high-risk cardiovascular disease patients. The Company is currently conducting three pivotal Phase 3 clinical trials of obicetrapib: BROOKLYN, evaluating the effect of obicetrapib on LDL-C levels in patients with heterozygous familial hypercholesterolemia (“HeFH”) as an adjunct to maximally tolerated lipid-lowering therapy; BROADWAY, evaluating the effect of obicetrapib on top of maximally tolerated lipid-lowering therapy in patients with HeFH and/or established atherosclerotic cardiovascular disease (“ASCVD”); and PREVAIL, a cardiovascular outcomes trial (“CVOT”) in patients with a history of ASCVD with inadequately controlled LDL-C despite treatment with maximally tolerated lipid-modifying therapies.
Corporate Updates:
Upcoming Potential Milestones:
NewAmsterdam currently expects to achieve the following upcoming milestones:
Financial Highlights:
Financial Guidance: Based on its current operating and development plans, NewAmsterdam believes that its existing cash will be sufficient to fund the Company’s operations through 2026, beyond the anticipated readout of its three ongoing Phase 3 trials, BROADWAY, BROOKLYN and PREVAIL.
About Obicetrapib
Obicetrapib is a novel, oral, low-dose CETP inhibitor that NewAmsterdam is developing to overcome the limitations of current LDL-lowering treatments. The Company believes that obicetrapib has the potential to be a once-daily oral CETP inhibitor for lowering LDL-C, if approved. In the Company’s Phase 2b ROSE trial, obicetrapib demonstrated a 51% lowering of LDL-C from baseline at a 10 mg dose level on top of high-intensity statins and, in the Company’s Phase 2 ROSE2 trial, the combination of a 10 mg dose of obicetrapib and a 10 mg dose of ezetimibe demonstrated a 63% lowering of LDL-C from baseline. In all five of the Company’s Phase 2 trials, ROSE2, TULIP, ROSE, OCEAN, and TA-8995-203, 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, including no increase in blood pressure or muscle related side effects. Obicetrapib has demonstrated strong tolerability in more than 800 patients with elevated lipid levels (“dyslipidemia”) in NewAmsterdam’s clinical trials to date. The Company is conducting two Phase 3 pivotal trials, BROADWAY and BROOKLYN, to evaluate obicetrapib as a monotherapy used as an adjunct to maximally tolerated lipid-lowering therapies to provide additional LDL-lowering for high-risk CVD patients. The Company began enrolling patients in BROADWAY in January 2022 and in BROOKLYN in July 2022 and completed enrollment of BROOKLYN in April 2023 and BROADWAY in July 2023. The Company also commenced the Phase 3 PREVAIL CVOT in March 2022, which is designed to assess the potential of obicetrapib to reduce occurrences of MACE, including cardiovascular death, non-fatal myocardial infarction, non-fatal stroke and non-elective coronary revascularization.
About NewAmsterdam
Based in the Netherlands, NewAmsterdam (Nasdaq: NAMS) is a clinical-stage biopharmaceutical company whose mission is to improve patient care in populations with metabolic diseases where currently approved therapies have not been sufficiently successful or well tolerated. There exists a significant unmet need for a potent, cost-effective and convenient LDL-lowering therapy as an adjunct to statins, a class of lipid-lowering medications that are the current standard of care for high-risk CVD patients with high cholesterol. NewAmsterdam is investigating obicetrapib, an oral, low-dose and once-daily CETP inhibitor, as the preferred LDL-C lowering therapy to be used as an adjunct to maximally tolerated statin therapy for high-risk cardiovascular disease patients.
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 business and strategic plans, cash runway, 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 and the achievement and timing of regulatory approvals. 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 relating to the uncertainty of the projected financial information with respect to the Company; risks related to the approval of the Company’s product candidate and the timing of expected regulatory and business milestones; 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 conflict; the effects of competition on the Company’s future business; and those factors described in the Company’s public filings with the U.S. Securities and 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
Jenn Gordon
P: 1-202-957-7795
jgordon@spectrumscience.com
Investor Contact
Stern Investor Relations on behalf of NewAmsterdam
Hannah Deresiewicz
P: 1-212-362-1200
hannah.deresiewicz@sternir.com
NewAmsterdam Pharma Company N.V. Condensed Consolidated Statements Of Profit Or Loss (Unaudited) |
|||||||||
For the six months ended June 30, | |||||||||
2023 | 2022 | ||||||||
(In thousands of Euro, except per share amounts) | |||||||||
Revenue | 9,562 | 93,500 | |||||||
Research and development expenses | (72,873 | ) | (30,588 | ) | |||||
Selling, general and administrative expenses | (13,736 | ) | (9,294 | ) | |||||
Total operating expenses | (86,609 | ) | (39,882 | ) | |||||
Operating (loss) / profit | (77,047 | ) | 53,618 | ||||||
Finance income | 5,176 | 10 | |||||||
Finance expense | (3 | ) | (185 | ) | |||||
Fair value change – earnout and warrants | (5,998 | ) | — | ||||||
Foreign exchange gains | 2,770 | 1,070 | |||||||
(Loss) / profit before tax | (75,102 | ) | 54,513 | ||||||
Income tax expense | — | — | |||||||
(Loss) / profit for the period | (75,102 | ) | 54,513 | ||||||
Earnings per share (in Euros) | |||||||||
Basic* | € | (0.92 | ) | € | 1.50 | ||||
Diluted* | € | (0.92 | ) | € | 1.35 |
NewAmsterdam Pharma Company N.V. Condensed Consolidated Statements Of Financial Position (Unaudited) |
||||||||
As at | ||||||||
June 30, 2023 |
December 31, 2022 |
|||||||
(In thousands of Euro) | ||||||||
Assets | ||||||||
Non-current assets | ||||||||
Intangible assets | 81,629 | 83,160 | ||||||
Property, plant and equipment | 112 | 144 | ||||||
Long term prepaid expenses | 93 | 146 | ||||||
Total non-current assets | 81,834 | 83,450 | ||||||
Current assets | ||||||||
Prepayments and other receivables | 5,769 | 9,611 | ||||||
Cash | 383,495 | 438,522 | ||||||
Total current assets | 389,264 | 448,133 | ||||||
Total assets | 471,098 | 531,583 | ||||||
Equity and liabilities | ||||||||
Equity | ||||||||
Share capital | 608,754 | 599,191 | ||||||
Other reserves | 16,852 | 4,691 | ||||||
Translation differences | (8,879 | ) | – | |||||
Accumulated loss | (194,463 | ) | (119,361 | ) | ||||
Total equity | 422,264 | 484,521 | ||||||
Non-current liabilities | ||||||||
Deferred revenue | 2,923 | 4,492 | ||||||
Lease liability | 23 | 56 | ||||||
Derivative earnout liability | 7,553 | 7,053 | ||||||
Total non-current liabilities | 10,499 | 11,601 | ||||||
Current liabilities | ||||||||
Trade and other payables | 20,854 | 18,503 | ||||||
Deferred revenue | 9,690 | 13,008 | ||||||
Lease liability | 64 | 62 | ||||||
Derivative warrant liabilities | 7,727 | 3,888 | ||||||
Total current liabilities | 38,335 | 35,461 | ||||||
Total equity and liabilities | 471,098 | 531,583 |
NewAmsterdam Pharma Company N.V. Condensed Consolidated Statements Of Cash Flows (Unaudited) |
||||||||
For the six months ended June 30, | ||||||||
2023 | 2022 | |||||||
(In thousands of Euro) | ||||||||
Operating activities: | ||||||||
Loss before tax | (75,102 | ) | 54,513 | |||||
Non-cash adjustments to reconcile loss before tax to net cash flows: | ||||||||
Depreciation and amortization | 34 | 36 | ||||||
Finance income | (5,176 | ) | (10 | ) | ||||
Finance expense | – | 5 | ||||||
Fair value change – derivative earnout and warrants | 5,998 | — | ||||||
Foreign exchange gains | (2,770 | ) | (1,070 | ) | ||||
Share-based compensation | 12,118 | 349 | ||||||
Changes in working capital: | ||||||||
Changes in trade receivables | – | (115,000 | ) | |||||
Changes in prepayments and other receivables | 3,686 | (6,692 | ) | |||||
Changes in trade and other payables | 2,893 | 1,727 | ||||||
Changes in deferred revenue | (4,590 | ) | 21,500 | |||||
Changes in non-current assets/liabilities | ||||||||
Changes in long-term prepaid expenses | 51 | — | ||||||
Interest paid | (3 | ) | — | |||||
Net cash provided by/(used in) operating activities | (62,861 | ) | (44,642 | ) | ||||
Investing activities: | ||||||||
Purchase of equipment | (4 | ) | (2 | ) | ||||
Interest received | 5,176 | |||||||
Net cash provided by/(used in) investing activities | 5,172 | (2 | ) | |||||
Financing activities: | ||||||||
Proceeds from issuing equity securities (Series A) | – | 79,680 | ||||||
Proceeds from issuing equity securities (exercise of Warrants) | 7,957 | — | ||||||
Proceeds from issuing equity securities (exercise of Company Options) | 96 | — | ||||||
Payments of lease liabilities | (30 | ) | (33 | ) | ||||
Net cash provided by financing activities | 8,023 | 79,647 | ||||||
Net change in cash | (49,666 | ) | 35,003 | |||||
Foreign exchange differences | (5,361 | ) | 1,383 | |||||
Cash at the beginning of the period | 438,522 | 53,092 | ||||||
Cash at the end of the period | 383,495 | 89,478 |
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