Core Insights - NewAmsterdam Pharma Company N.V. has appointed Mark C. McKenna and Wouter Joustra as temporary non-executive directors to its Board of Directors, filling vacant positions until the next annual general meeting [1][2] - The company announced the departure of Sander Slootweg from its Board of Directors, effective July 16, 2024 [1] Company Overview - NewAmsterdam Pharma is a late-stage clinical biopharmaceutical company focused on developing oral, non-statin medicines for patients at risk of cardiovascular disease (CVD) with elevated low-density lipoprotein cholesterol (LDL-C) [6] - The company aims to address unmet needs for safe, well-tolerated, and convenient LDL-lowering therapies, particularly through its ongoing Phase 3 studies of obicetrapib, a CETP inhibitor [6] Leadership Experience - Mark C. McKenna brings over 20 years of pharmaceutical industry experience, having held leadership roles in various companies, including Prometheus Biosciences, which was acquired by Merck for approximately $10.8 billion in June 2023 [2][3] - Wouter Joustra has extensive experience in capital markets and life sciences investments, currently serving as a General Partner at Forbion, a global life sciences venture capital firm [3][4] Strategic Importance - The appointments of McKenna and Joustra are seen as strategic moves as NewAmsterdam approaches pivotal Phase 3 data readouts from multiple ongoing clinical trials [2] - Both new board members express confidence in the company's potential to impact the CVD treatment landscape significantly [3][5]

Company Overview - Apogee Therapeutics Inc (NASDAQ: APGE) is a biotechnology company focused on developing innovative therapies for chronic and prevalent conditions such as atopic dermatitis (AD) and asthma [1][3] - The company's lead clinical candidate, APG777, is a Phase 1 SQ monoclonal antibody targeting IL13, with dosing frequency of every three to six months, potentially offering a significant improvement over existing treatments like Dupixent [1][3] - Apogee is also developing APG808, a novel SQ half-life extended mAb targeting IL-4Rα, for type 2 allergic diseases like asthma and COPD, aiming to compete in Dupixent's market [3] Clinical Progress - APG777 has advanced to a Phase 2 clinical trial (NCT06395948) in patients with moderate-to-severe atopic dermatitis, with proof-of-concept data expected in 2H 2025 [3] - The company anticipates initiating a Phase 2 clinical trial for APG777 in asthma next year, targeting two large markets: AD (projected to reach over $18 billion by 2032) and asthma (currently valued at near $25 billion) [3] - APG777's extended-release mechanism could differentiate it from existing drugs like Dupixent, with clinical risks slightly reduced due to its validated MOA [5] Financial Health - As of March 31, Apogee has $485 457 million in cash and cash equivalents and $330 739 million in marketable securities, with no major liabilities [4] - Q1 R&D and G&A expenses totaled $28 716 million and $9 465 million, respectively, with a cash runway estimated to extend into 2028 based on current liquid assets and operating expenses [4] - The company raised $420 million in capital at $62/share in March, a strategic move given the high costs associated with advancing clinical candidates into late-stage trials [2][5] Market and Competitive Landscape - The AD and asthma markets are substantial, with AD projected to grow to over $18 billion by 2032 and asthma currently valued at near $25 billion [3] - APG777 and APG808 aim to compete with Dupixent, which has a speculated peak annual revenue of over $20 billion following its success in COPD [3] - Historical examples like Humira and Enbrel in rheumatoid arthritis, and Aimovig in migraine, demonstrate the market preference for less frequent dosing, which could benefit APG777 if it demonstrates non-inferiority to Dupixent [3] Investment Considerations - APGE stock has declined by 34% since March, while the S&P 500 Index has risen by 7 7%, potentially due to a lack of major catalysts and a weaker biotech sector [1][3] - The company's progress with APG777 and APG808, combined with its strong financial position, suggests potential for long-term growth, though significant operating cost increases are expected as clinical trials advance [4][5] - APGE is recommended as a high-risk/high-reward stock, suitable for a barbell portfolio strategy with 10% allocation to such stocks, allowing investors to benefit from upside potential while mitigating risk [7]

Core Insights - Apogee Therapeutics, Inc. has appointed Dr. Lisa Bollinger to its board of directors, bringing over 30 years of experience in drug development and regulatory affairs [1][2][3] - The company is advancing its clinical pipeline for atopic dermatitis, chronic obstructive pulmonary disease (COPD), and other inflammatory and immunology indications, with two programs currently in clinical development and a third expected in the second half of 2024 [2][4] Company Overview - Apogee Therapeutics is a clinical-stage biotechnology company focused on developing differentiated biologics for high unmet needs in atopic dermatitis, COPD, asthma, and other inflammatory and immunology conditions [4] - The company's advanced programs, APG777 and APG808, are designed to improve upon existing therapies by targeting established mechanisms of action and utilizing advanced antibody engineering to enhance properties such as half-life [4] Leadership and Expertise - Dr. Bollinger's previous roles include Vice President of Regulatory Affairs at Merck and significant experience at Amgen and the U.S. FDA, where she oversaw pediatric drug development and safety [1][2][3] - The leadership team at Apogee is positioned to leverage Dr. Bollinger's regulatory insights and clinical expertise to navigate the complexities of drug development and regulatory approval processes [2][3]

SAN FRANCISCO and WALTHAM, Mass., May 23, 2024 (GLOBE NEWSWIRE) -- Apogee Therapeutics, Inc. (NASDAQ:APGE), a clinical-stage biotechnology company advancing differentiated biologics for the treatment of atopic dermatitis, COPD, asthma and other inflammatory and immunology indications, today announced that members of management will participate at the following upcoming investor conferences: Jefferies Global Healthcare Conference Date: Thursday, June 6, 2024Time: 8:30 a.m. ET Goldman Sachs 45th Annual Global ...

Interim clinical data from APG777 Phase 1 healthy volunteers study exceeded all trial objectives and achieved a half-life of approximately 75 days with a potentially best-in-class profile 16-week proof-of-concept data from Part A of the Phase 2 trial expected in 2H 2025 Pipeline-in-a-product potential with a Phase 2 in asthma expected to initiate in 2025 and plans for additional indication expansion SAN FRANCISCO and WALTHAM, Mass., May 15, 2024 (GLOBE NEWSWIRE) -- Apogee Therapeutics, Inc. (NASDAQ:APGE), a ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-41740 Apogee Therapeutics, Inc. (Exact name of registrant as specified in its charter) Delaware 93-4958665 (Sta ...

Companies have generally managed to perform well against the consensus of earnings forecasts, with around 77% of S&P 500 firms reporting in Q1 considered earnings outperformers. That rate is higher than the normal rate of around 74% recorded in the first three months of a year, with earnings outperformers beating historical trends.The main theme of this quarter’s earnings reports has been artificial intelligence, with companies reporting soaring spending on the technology. Not surprisingly, AI-based and adj ...

Company Overview - Apogee Therapeutics, Inc. is a clinical-stage biotechnology company focused on developing differentiated biologics for treating atopic dermatitis, chronic obstructive pulmonary disease, asthma, and other inflammatory and immunology indications [5] - The company aims to address high unmet medical needs by utilizing advanced antibody engineering to optimize therapeutic properties [5] Recent Financial Activity - Apogee announced the closing of an upsized public offering of 7,790,321 shares of common stock at a public offering price of $62.00 per share, resulting in gross proceeds of approximately $483.0 million before expenses [1] - The offering included the full exercise of the underwriters' option to purchase an additional 1,016,128 shares [1] Underwriters - Jefferies, BofA Securities, Goldman Sachs & Co. LLC, TD Cowen, and Stifel acted as joint book-running managers for the offering [2]

SAN FRANCISCO and WALTHAM, Mass., March 07, 2024 (GLOBE NEWSWIRE) -- Apogee Therapeutics, Inc. (NASDAQ:APGE), a clinical-stage biotechnology company seeking to develop differentiated biologics for the treatment of atopic dermatitis, chronic obstructive pulmonary disease, asthma and other inflammatory and immunology indications (Apogee or the Company), today announced the pricing of its upsized previously announced underwritten public offering of 6,774,193 shares of common stock at a public offering price pe ...

Sviatlana Lazarenka/iStock via Getty Images Apogee Therapeutics, Inc. (NASDAQ:APGE) has reported positive results from its phase 1 study using its lead candidate APG777 for the treatment of patients with moderate-to-severe Atopic Dermatitis [AD] and other inflammatory disorders. The last time I went over this biotech, it had not yet reported this data. At the time, I believed that it could create a competitive edge over other IL-13 biologics based on half-life improvement. That is, how long drug exposur ...