{"id":50581,"date":"2023-08-19T18:09:31","date_gmt":"2023-08-19T22:09:31","guid":{"rendered":"https:\/\/ifintechworld.com\/news\/newamsterdam-pharma-best-cardiovascular-biotech-in-2023-nasdaqnams\/"},"modified":"2023-08-19T18:09:35","modified_gmt":"2023-08-19T22:09:35","slug":"newamsterdam-pharma-best-cardiovascular-biotech-in-2023-nasdaqnams","status":"publish","type":"post","link":"https:\/\/ifintechworld.com\/?p=50581","title":{"rendered":"NewAmsterdam Pharma: Best Cardiovascular Biotech In 2023 (NASDAQ:NAMS)"},"content":{"rendered":"
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Q2 earnings summary – Maintaining a Buy Rating on NAMS<\/strong><\/h2>\n

Although we had written an article recently before the earnings where we focused on the evolving landscape of LDL-c lowering therapies, we decided to write a follow-up article to discuss the new updates from the Q2 earnings as new details around the upcoming clinical readouts of phase 3 trials were discussed. We believe the two pivotal phase 3 data would be key for investors to follow as it will determine if Obi can get approved just based on a standalone LDL-c reduction or if CVOT data would be required. <\/span><\/p>\n

Q2 2023 Earnings Update:<\/strong> In its 2Q23 financial report, NewAmsterdam Pharma (NASDAQ:NAMS<\/span>) showcased a positive trajectory, echoing confidence in its next-gen oral CETPi obicetrapib. This potential treatment targets a significant unmet need in cardiovascular patients unable to achieve their desired LDL-C goals through a novel CETP inhibitor that can be taken orally. <\/span><\/p>\n

A notable update that was shared by the management was around over-enrollment in obi\u2019s Ph.3 BROADWAY trial (>2500 against a target of 2400), hinting at a robust global demand for innovative oral statin adjunct therapies.<\/p>\n

The company’s lead asset Obicetrapib, currently in three Ph.3 trials, is set to present top-line data from its LDL-lowering studies in 2H24 (which the company needs for the full approval as we have seen with PCKS9is). We expect approval of the drug by 2025-2026 and we build conviction on the approvability if the drug’s phase 2b ROSE trial’s data holds. Even though we consider that the outcomes data is necessary for payer and commercial uptake (because guidelines would usually value CVOT outcomes over surrogate endpoints like LDL-c), we do not believe regulators would require that for approval provided that LDL-c is robust (>50% LDL-c reduction from baseline similar to the previous ROSE phase 2b trial.<\/p>\n

Furthermore, we believe NAM’s robust financial position is highly assuring, the company ended 2Q23 with approximately \u20ac384M, which should offer a cash runway up until 2026 after late stage clinical readout for its phase 3 programs has read out (and stock to substantially appreciate provided that the data is positive). <\/p>\n

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Company pipeline overview (NAMS)<\/span><\/p>\n<\/figcaption><\/figure>\n

Key Catalysts & NAMS\u2019s pipeline<\/strong><\/h2>\n

NAMS’ pipeline, particularly obicetrapib, represents a groundbreaking approach to cholesterol management. Enrollment for its pivotal LDL-lowering Phase III trials has not only been completed timely but also over-enrolled, indicating strong interest and potential future uptake. The prospective LDL reduction rates, especially the anticipated ~60% for the combo, set obicetrapib on par with injectable PCSK9 but with the convenience of oral administration. Of note, we remind readers that the current PCSK9i’s adoption was underwhelming mainly because of the market access (payer reimbursement, price, administrative burden coming from Medicare part B (for Leqvio’s case)); as such, we believe the oral dosage form and novel mechanism action of Obi should allow the drug’s sales to ramp up much faster. <\/p>\n

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Comparative table (NAMS)<\/span><\/p>\n<\/figcaption><\/figure>\n

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Current PCSK9i landscape summary<\/p>\n

<\/span><\/p>\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n
<\/th>\n<\/td>\n<\/td>\n<\/td>\n<\/tr>\n<\/thead>\n
Project<\/strong><\/td>\nCompany<\/strong><\/td>\nDescription<\/strong><\/td>\nNote<\/strong><\/td>\n<\/tr>\n
Phase 2<\/strong><\/em><\/td>\n<\/tr>\n
MK-0616<\/td>\nMerck & Co<\/td>\nOnce-daily oral<\/td>\n Ph2 data at ACC 2023, ph3 planned in H2 2023<\/td>\n<\/tr>\n
Phase 1<\/strong><\/em><\/td>\n<\/tr>\n
AZD0780<\/td>\nAstrazeneca<\/td>\nOral<\/td>\n A Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AZD0780 in Healthy Subjects – Full Text View – ClinicalTrials.gov in healthy volunteers; data due H2 2023<\/td>\n<\/tr>\n
VERVE-101<\/td>\nVerve Therapeutics<\/td>\nOne-off in vivo gene editing<\/td>\n Heart-1 enrolling in New Zealand & UK, first data due H2 2023; US IND on clinical hold<\/td>\n<\/tr>\n
Preclinical<\/strong><\/em><\/td>\n<\/tr>\n
VXX-401<\/td>\nVaxxinity<\/td>\n“Long-acting” synthetic peptide vaccine; target 2-4 per year<\/td>\n Preclinical data at ACC 2023; ph1 slated for H1 2023<\/td>\n<\/tr>\n
CTX330<\/td>\nCrispr Therapeutics<\/td>\nOne-off in vivo gene editing<\/td>\n<\/tr>\n
STP135G<\/td>\nSirnaomics<\/td>\nSC RNAi<\/td>\n<\/tr>\n
Fallen by the wayside<\/strong><\/em><\/td>\n<\/tr>\n
ION449 (AZD8233)<\/td>\nAstrazeneca\/Ionis<\/td>\nOnce-monthly SC antisense<\/td>\nAstra not taking into ph3 following ph2 Solano data<\/td>\n<\/tr>\n
NN6435\/ NNC0385-0434<\/td>\nNovo Nordisk<\/td>\nOral<\/td>\nCompany had ph2 data in Q3 2022; no longer in pipeline<\/td>\n<\/tr>\n
PBGENE-PCSK9<\/td>\nPrecision Biosciences\/Iecure<\/td>\nOne-off in vivo gene editing<\/td>\nDiscontinued at preclinical stage<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

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