NewAmsterdam Pharma Company N.V Stock Price, News & Analysis

NewAmsterdam Pharma (Nasdaq: NAMS), a late-stage clinical biopharmaceutical company focused on developing oral, non-statin medicines for cardiovascular disease patients with elevated LDL-C, has announced its participation in the Guggenheim SMID Cap Biotech Conference.

The company's Chief Financial Officer, Ian Somaiya, will engage in a fireside chat on Wednesday, February 5, 2025, at 10:00 a.m. ET. Investors and interested parties can access the live webcast through NewAmsterdam Pharma's investor relations website at ir.newamsterdampharma.com. An archived replay will be available on the company's website following the live presentation.

NewAmsterdam Pharma (NAMS) provided updates on its obicetrapib clinical development program and 2025 strategic priorities. The company reported positive topline results from three Phase 3 trials in 2024: BROADWAY showed 33% LDL-C reduction and 21% MACE reduction; TANDEM achieved 49% LDL-C reduction with fixed-dose combination; and BROOKLYN demonstrated 36% LDL-C reduction.

The company completed enrollment of over 9,500 patients in the PREVAIL cardiovascular outcomes trial. Additional data from these trials will be presented throughout 2025, supporting global regulatory filings including EMA submission in 2H25. The Phase 2 VINCENT trial, exploring obicetrapib's effect on Lp(a), is expected to report data in 2H25.

NewAmsterdam ended 2024 with an unaudited cash balance of $835 million following an oversubscribed public offering. The company secured patent protection for obicetrapib until July 2043 and is focusing on commercial readiness with manufacturing capacity establishment.

NewAmsterdam Pharma (Nasdaq: NAMS) announced the approval of inducement grants by its Board's Compensation Committee. The grants include share options for 58,000 ordinary shares to two non-executive new hires and 170,800 ordinary shares to Maryellen McQuade, the new Chief People Officer, at an exercise price of $25.94 per share.

The share options will vest over four years, with 25% vesting after one year and the remainder vesting in 36 monthly installments. Additionally, McQuade received 36,600 restricted stock units that will vest over three years, with one-third vesting annually. These grants were made under the 2024 Inducement Plan in accordance with Nasdaq Listing Rule 5635(c)(4).

Menarini Group announced positive topline data from two Phase 3 trials evaluating Obicetrapib. The BROADWAY trial showed Obicetrapib achieved a 33% LDL-C reduction compared to placebo (p<0.0001), with 50% of patients reaching LDL-C levels below 55 mg/dL. A 21% reduction in major adverse cardiovascular events was observed at one year.

The TANDEM trial, testing a fixed-dose combination of Obicetrapib with Ezetimibe, demonstrated a 48.6% LDL-C reduction (p<0.0001), with over 70% of patients achieving target LDL-C levels. Both treatments were well-tolerated with safety profiles comparable to placebo. These trials are part of a larger Phase 3 program including over 12,250 patients across four studies.

NewAmsterdam Pharma (NAMS) has successfully closed its upsized public offering, raising $479.0 million through the sale of securities. The offering included 14,667,347 ordinary shares at $24.50 per share and pre-funded warrants to purchase 4,882,653 ordinary shares at $24.4999 per warrant. The underwriters fully exercised their option to purchase an additional 2,550,000 ordinary shares.

After deducting underwriting discounts, commissions, and estimated offering expenses, the company received net proceeds of approximately $452.6 million. The offering was conducted through multiple joint book-running managers, including Jefferies, Goldman Sachs, Leerink Partners, TD Cowen, Guggenheim Securities, and William Blair.

NewAmsterdam Pharma (NAMS) has announced the pricing of its upsized public offering, consisting of 12,117,347 ordinary shares at $24.50 per share and pre-funded warrants to purchase 4,882,653 ordinary shares at $24.4999 per warrant. The offering is expected to generate approximately $416.5 million in proceeds before deducting expenses.

The company has granted underwriters a 30-day option to purchase up to an additional 2,550,000 ordinary shares. The offering is expected to close around December 13, 2024. Multiple investment banks, including Jefferies, Goldman Sachs, Leerink Partners, TD Cowen, Guggenheim Securities, and William Blair, are acting as joint book-running managers.

NewAmsterdam Pharma (Nasdaq: NAMS) has announced the commencement of a $300 million public offering of ordinary shares and pre-funded warrants. The company is offering investors the choice between ordinary shares and pre-funded warrants to purchase ordinary shares. Additionally, underwriters will receive a 30-day option to purchase up to an additional $45 million of ordinary shares.

The offering will be conducted through multiple joint book-running managers including Jefferies, Goldman Sachs & Co., Leerink Partners, TD Cowen, Guggenheim Securities, and William Blair. The offering will be made pursuant to a registration statement on Form S-3 that was declared effective by the SEC on July 12, 2024.

NewAmsterdam Pharma announced positive topline data from its Phase 3 BROADWAY clinical trial evaluating obicetrapib in patients with cardiovascular disease and heterozygous familial hypercholesterolemia. The trial achieved its primary endpoint with a statistically significant 33% reduction in LDL-C compared to placebo (p<0.0001).

Key findings include a 21% reduction in major adverse cardiovascular events favoring obicetrapib at one year. The drug demonstrated favorable safety results comparable to placebo, with treatment discontinuation rates of 11.1% for obicetrapib versus 12.4% for placebo. The trial involved 2,530 patients randomized 2:1 to receive 10mg obicetrapib or placebo daily for 52 weeks.

NewAmsterdam Pharma (Nasdaq: NAMS) announced that its Compensation Committee approved inducement share options for 79,000 ordinary shares to two non-executive new hires. The options, granted under the 2024 Inducement Plan and compliant with Nasdaq Rule 5635(c)(4), have an exercise price of $19.64 per share, based on the December 2, 2024 closing price. The shares will vest over four years, with 25% vesting after one year and the remaining vesting monthly over 36 months, contingent on continued employment.