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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549

 

FORM 8-K

 

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): November 6, 2024

 

 

NewAmsterdam Pharma Company N.V.

(Exact name of Registrant as Specified in Its Charter)

 

 

The Netherlands			001-41562	N/A
(State or Other Jurisdiction of Incorporation)			(Commission File Number)	(IRS Employer Identification No.)
Goomieer 2-35
Naarden
The Netherlands				1411 DC
(Address of Principal Executive Offices)				(Zip Code)
			+31 (0) 35 206 2971
(Registrant’s Telephone Number, Including Area Code)

 

 

Not Applicable

(Former Name or Former Address, if Changed Since Last Report)

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

 

☐	Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
☐	Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
☐	Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
☐	Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each class		Trading Symbol(s)		Name of each exchange on which registered
Ordinary shares, nominal value €0.12 per share		NAMS		The Nasdaq Stock Market LLC
Warrants to purchase ordinary shares		NAMSW		The Nasdaq Stock Market LLC

 

☒	Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
☐	If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.

 

 

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Item 2.02 Results of Operations and Financial Condition.

On November 6, 2024, NewAmsterdam Pharma Company N.V. (the “Company”) issued a press release announcing corporate updates and its financial results for the quarter ended September 30, 2024. A copy of the press release is furnished as Exhibit 99.1 hereto.

 

In accordance with General Instruction B.2 of Form 8-K, the information included in Item 2.02 of this Current Report on Form 8-K (including Exhibit 99.1 hereto), shall not be deemed “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference into any filing made by the Company under the Exchange Act or Securities Act of 1933, as amended, except as shall be expressly set forth by specific reference in such a filing.

Item 9.01 Financial Statements and Exhibits.

(d)	Exhibits.

Exhibit No.		Description
99.1		NewAmsterdam Pharma Company N.V. Press Release, dated November 6, 2024
104		Cover Page Interactive Data File (embedded within the Inline XBRL document)

 

 

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SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

			NewAmsterdam Pharma Company N.V.
Date:	November 6, 2024	By:	/s/ Michael Davidson
		Name:	Michael Davidson, M.D.
		Title:	Chief Executive Officer

 

 

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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, USA; November 6, 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 (“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.

 

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:

 

Third Quarter Financial Results

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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

 

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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

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Austin Murtagh

P: 1-212-698-8696

austin.murtagh@precisionaq.com

 

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Financial Tables

 

NewAmsterdam Pharma Company N.V.

Condensed Consolidated Balance Sheets

(Unaudited)

	September 30, 2024				December 31, 2023
(In thousands of USD)
Assets
Current assets:
Cash		422,729				340,450
Prepayments and other receivables		15,145				6,341
Total current assets		437,874				346,791
Property, plant and equipment, net		231				46
Operating right of use asset		493				55
Intangible assets		593				170
Long term prepaid expenses		-				35
Total assets		439,191				347,097
Liabilities and Shareholders' Equity
Current liabilities:
Accounts payable		7,039				16,923
Accrued expenses and other current liabilities		10,580				11,398
Deferred revenue, current		4,495				8,942
Lease liability, current		240				60
Derivative warrant liabilities		18,901				12,574
Total current liabilities		41,255				49,897
Deferred revenue, net of current portion		-				1,019
Lease liability, net of current portion		266				-
Derivative earnout liability		18,808				7,788
Total liabilities		60,329				58,704
Commitments and contingencies (Note 10)
Shareholders' Equity (deficit):
Ordinary shares, €0.12 par value; 400,000,000 shares authorized; 92,165,605 and 82,469,768 shares issued and outstanding as at September 30, 2024 and December 31, 2023, respectively		11,435				10,173
Additional paid-in capital		829,399				590,771
Accumulated loss		(466,394	)			(316,973	)
Accumulated other comprehensive income		4,422				4,422
Total shareholders' equity		378,862				288,393
Total liabilities and shareholders' equity		439,191				347,097

 

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NewAmsterdam Pharma Company N.V.

Condensed Consolidated Statements of Operations and Comprehensive Income (Loss)

(Unaudited)

	For the three months ended September 30,								For the nine months ended September 30,
	2024				2023				2024				2023
(In thousands of USD, except share and per share amounts)
Revenue		29,111				2,941				32,791				13,287
Operating expenses:
Research and development expenses		35,702				43,371				116,511				118,132
Selling, general and administrative expenses		18,412				9,128				49,340				27,048
Total operating expenses		54,114				52,499				165,851				145,180
Operating loss		(25,003	)			(49,558	)			(133,060	)			(131,893	)
Other income (expense):
Interest income		4,443				3,059				12,396				8,615
Fair value change – earnout and warrants		(770	)			2,521				(30,028	)			(4,004	)
Foreign exchange gains/(losses)		4,682				(3,155	)			1,270				(160	)
Loss before tax		(16,648	)			(47,133	)			(149,422	)			(127,442	)
Income tax expense		(1	)			—				(1	)			—
Loss and comprehensive loss for the period		(16,647	)			(47,133	)			(149,421	)			(127,442	)
Net loss per ordinary share:
Basic and diluted net loss per ordinary share	$	(0.18	)		$	(0.57	)		$	(1.61	)		$	(1.55	)
Basic and diluted weighted average number of ordinary shares outstanding		94,754,140				82,466,584				92,666,874				82,058,225

 

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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
Exercise of warrants		100				0				1				—				—				1
Exercise of stock options		145,337				19				166				—				—				185
Share-based compensation		—				—				5,439				—				—				5,439
Total loss and comprehensive loss for the period		—				—				—				(47,133	)			—				(47,133	)
As at September 30, 2023		82,469,768				10,173				584,718				(267,478	)			4,422				331,835
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
Exercise of Pre-Funded Warrants		2,105,248				279				(279	)			—				—				—
Exercise of stock options		45,000				5				53				—				—				58
Share-based compensation		—				—				8,012				—				—				8,012
Total loss and comprehensive loss for the period		—				—				—				(16,647	)			—				(16,647	)
As at September 30, 2024		92,165,605				11,435				829,399				(466,394	)			4,422				378,862

 

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NewAmsterdam Pharma Company N.V.

Condensed Consolidated Statements of Cash Flows

(Unaudited)

	For the nine months ended September 30,
	2024				2023
(In thousands of USD)
Operating activities:
Loss for the period		(149,421	)			(127,442	)
Non-cash adjustments to reconcile loss before tax to net cash flows:
Depreciation and amortization		62				36
Non-cash rent expense		8				5
Fair value change - derivative earnout and warrants		30,028				4,004
Foreign exchange (gains)/losses		(1,270	)			160
Share-based compensation		24,204				18,566
Changes in working capital:
Changes in prepayments (current and non-current) and other receivables		(8,769	)			988
Changes in accounts payable		(9,751	)			(7,824	)
Changes in accrued expenses and other current liabilities		(708	)			11,266
Changes in deferred revenue		(5,466	)			(7,903	)
Net cash (used in)/provided by operating activities		(121,083	)			(108,144	)
Investing activities:
Purchase of property, plant and equipment, including internal use software		(669	)			(21	)
Net cash used in investing activities		(669	)			(21	)
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				8,622
Proceeds from exercise of options		498				290
Payment of withholding taxes related to net share settlement of exercised options		(989	)			—
Net cash provided by financing activities		202,896				8,912
Net change in cash		81,144				(99,253	)
Foreign exchange differences		1,135				(168	)
Cash at the beginning of the period		340,450				467,728
Cash at the end of the period		422,729				368,307
Noncash financing and investing activities
Right-of-use assets obtained in exchange for new operating lease liabilities		562				—

 

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