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Apogee Therapeutics to Participate at the Stifel 2024 Immunology and Inflammation Summit
GlobeNewswire News Room· 2024-09-12 11:00
Core Insights - Apogee Therapeutics, Inc. is a clinical-stage biotechnology company focused on developing novel biologics for inflammatory and immunology (I&I) markets, targeting conditions such as atopic dermatitis (AD), asthma, and chronic obstructive pulmonary disease (COPD) [2] Company Overview - Apogee Therapeutics aims to provide differentiated efficacy and dosing in the I&I markets, with a particular focus on AD, which is noted as the largest and least penetrated market in this sector [2] - The company is advancing its antibody programs to address limitations of existing therapies by targeting established mechanisms of action and utilizing advanced antibody engineering to enhance properties like half-life [2] - APG777 is the most advanced program of the company, initially developed for the treatment of AD [2] - Apogee has four validated targets in its portfolio and is pursuing best-in-class efficacy through both monotherapies and combinations of its novel antibodies [2] - The company believes its broad pipeline and expertise can deliver significant value and benefits to patients who are underserved by current standard care [2]
Apogee Therapeutics(APGE) - 2024 Q2 - Quarterly Report
2024-08-12 11:00
PART I: FINANCIAL INFORMATION [Condensed Consolidated Financial Statements (Unaudited)](index=5&type=section&id=Item%201.%20Condensed%20Consolidated%20Financial%20Statements%20(Unaudited)) Apogee Therapeutics' unaudited interim financial statements reflect increased cash and marketable securities from a stock offering and a growing net loss due to higher R&D Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | June 30, 2024 | December 31, 2023 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $307,299 | $118,316 | | Marketable securities (Current & Long-term) | $482,324 | $277,143 | | **Total Assets** | **$800,657** | **$401,404** | | **Liabilities & Equity** | | | | Total Liabilities | $27,018 | $21,491 | | Total Stockholders' Equity | $773,639 | $379,913 | Condensed Consolidated Statement of Operations Highlights (in thousands) | Item | Three Months Ended June 30, 2024 | Three Months Ended June 30, 2023 | Six Months Ended June 30, 2024 | Six Months Ended June 30, 2023 | | :--- | :--- | :--- | :--- | :--- | | Research and development | $33,206 | $13,946 | $61,922 | $22,401 | | General and administrative | $10,916 | $4,939 | $20,381 | $9,142 | | **Loss from operations** | **$(44,122)** | **$(18,885)** | **$(82,303)** | **$(31,543)** | | Interest income, net | $10,306 | $— | $16,393 | $133 | | **Net loss** | **$(33,816)** | **$(18,885)** | **$(65,910)** | **$(31,410)** | | **Net loss per share** | **$(0.60)** | **$(3.78)** | **$(1.24)** | **$(6.28)** | Condensed Consolidated Statement of Cash Flows Highlights (in thousands) | Cash Flow Activity | Six Months Ended June 30, 2024 | Six Months Ended June 30, 2023 | | :--- | :--- | :--- | | Net cash used in operating activities | $(60,936) | $(25,127) | | Net cash used in investing activities | $(200,451) | $— | | Net cash provided by financing activities | $450,370 | $(1,694) | - The company is a clinical-stage biotechnology firm focused on inflammatory and immunology (I&I) indications like atopic dermatitis (AD), asthma, and COPD, having funded operations through preferred unit and common stock sales without generating revenue[36](index=36&type=chunk)[44](index=44&type=chunk) - The company believes its existing cash, cash equivalents, and marketable securities of approximately **$789.6 million** as of June 30, 2024, are sufficient to fund operations through at least the next 12 months from the financial statement issuance date[46](index=46&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=44&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses Apogee's business, pipeline advancements, financial results, and liquidity, noting a strengthened cash position and increased R&D expenses [Overview and Pipeline Update](index=44&type=section&id=MD%26A_Overview) Apogee advanced APG777 into Phase 2, APG808 into Phase 1, and plans APG990 for Phase 1, securing **$450.0 million** from a March 2024 offering - **APG777 (anti-IL-13):** Dosing commenced in a Phase 2 clinical trial for moderate-to-severe Atopic Dermatitis (AD) in May 2024, with topline 16-week data from Part A expected in the second half of 2025[165](index=165&type=chunk) - **APG808 (anti-IL-4Rα):** A Phase 1 trial was initiated in March 2024, with interim Phase 1 PK and safety data expected in Q4 2024 and initial proof-of-concept data in asthma anticipated in H1 2025[169](index=169&type=chunk) - **APG990 (anti-OX40L):** A development candidate was nominated in May 2024, and the company plans to initiate a Phase 1 clinical trial in healthy volunteers in Q3 2024[168](index=168&type=chunk) - **APG333 (anti-TSLP):** A development candidate is planned to be nominated by the end of 2024, with a Phase 1 trial expected to start in 2025[170](index=170&type=chunk) - In March 2024, the company completed a public offering, selling 7,790,321 shares of common stock for aggregate net proceeds of **$450.0 million**[173](index=173&type=chunk) [Results of Operations](index=59&type=section&id=MD%26A_Results_of_Operations) Operating expenses, especially R&D, significantly increased due to clinical advancements and personnel costs, while interest income rose sharply Comparison of Operating Results (in thousands) | Period | R&D Expense | G&A Expense | Loss from Operations | Net Loss | | :--- | :--- | :--- | :--- | :--- | | **Q2 2024** | $33,206 | $10,916 | $(44,122) | $(33,816) | | **Q2 2023** | $13,946 | $4,939 | $(18,885) | $(18,885) | | **H1 2024** | $61,922 | $20,381 | $(82,303) | $(65,910) | | **H1 2023** | $22,401 | $9,142 | $(31,543) | $(31,410) | R&D Expense Breakdown - Six Months Ended June 30 (in thousands) | Program/Category | 2024 | 2023 | | :--- | :--- | :--- | | APG777 | $14,094 | $11,773 | | APG808 | $6,172 | $— | | APG990 | $10,883 | $— | | Unallocated R&D Costs | $13,004 | $8,784 | | Personnel-related | $17,769 | $1,844 | | **Total R&D** | **$61,922** | **$22,401** | - The increase in R&D expenses for H1 2024 was driven by advancing the pipeline, including a **$2.0 million** milestone payment for APG808's first dosing in a Phase 1 trial and a **$1.0 million** milestone for APG990's development candidate nomination, with personnel-related R&D costs increasing by **$15.9 million** due to higher headcount and share-based compensation[227](index=227&type=chunk) - General and administrative expenses for H1 2024 increased by **$11.2 million** compared to H1 2023, primarily due to an **$8.2 million** increase in personnel costs and a **$3.2 million** increase in other expenses related to operational expansion and public company costs[228](index=228&type=chunk) [Liquidity and Capital Resources](index=65&type=section&id=MD%26A_Liquidity_and_Capital_Resources) As of June 30, 2024, the company held **$307.3 million** cash and **$482.3 million** marketable securities, sufficient to fund operations into Q1 2028 Cash Position and Recent Financing (in millions) | Item | Amount | | :--- | :--- | | Cash and cash equivalents (June 30, 2024) | $307.3 | | Marketable securities (June 30, 2024) | $482.3 | | Net proceeds from July 2023 IPO | $315.4 | | Net proceeds from March 2024 Offering | $450.0 | - Based on the current operating plan, the company estimates its existing cash, cash equivalents, and marketable securities will fund operating expenses and capital expenditure requirements into the first quarter of 2028[245](index=245&type=chunk)[273](index=273&type=chunk) - Net cash used in operating activities for the six months ended June 30, 2024, was **$60.9 million**, primarily due to the net loss of **$65.9 million**, adjusted for non-cash items like equity-based compensation[233](index=233&type=chunk)[235](index=235&type=chunk) - Net cash provided by financing activities was **$450.4 million** for the six months ended June 30, 2024, mainly from the March 2024 public offering[238](index=238&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=70&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) As a smaller reporting company, Apogee Therapeutics is exempt from providing market risk disclosures - The company is a smaller reporting company as defined in Rule 12b-2 of the Exchange Act and is not required to provide the information under this item[256](index=256&type=chunk) [Controls and Procedures](index=72&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded the company's disclosure controls were effective as of June 30, 2024, with no material changes to internal controls - Management concluded that as of June 30, 2024, the company's disclosure controls and procedures were effective at the reasonable assurance level[257](index=257&type=chunk) - There were no changes in the company's internal control over financial reporting during the quarter ended June 30, 2024, that have materially affected, or are reasonably likely to materially affect, internal controls[258](index=258&type=chunk) PART II: OTHER INFORMATION [Legal Proceedings](index=73&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently involved in any material legal proceedings, and management anticipates no material adverse effects - The company is not currently a party to any material legal proceedings[261](index=261&type=chunk) [Risk Factors](index=73&type=section&id=Item%201A.%20Risk%20Factors) This section details substantial investment risks, including Apogee's limited operating history, lead program dependence, and need for additional capital - The company is a clinical-stage entity with a limited operating history, no approved products, and a history of significant losses, making it difficult to evaluate its future success[263](index=263&type=chunk)[266](index=266&type=chunk) - Substantial additional capital will be required to finance operations, and failure to raise capital when needed could force delays or elimination of development programs[263](index=263&type=chunk)[268](index=268&type=chunk) - The company is substantially dependent on the success of its most advanced programs, APG777, APG808, and APG990, which are still in clinical development and may not be successful[263](index=263&type=chunk)[295](index=295&type=chunk) - The company relies on third parties, such as Paragon for discovery and WuXi Biologics for manufacturing, and any failure by these parties to perform could negatively impact the business[263](index=263&type=chunk)[327](index=327&type=chunk)[336](index=336&type=chunk) - The company's ability to protect its patents and proprietary rights is uncertain, and it may face costly infringement claims[263](index=263&type=chunk)[359](index=359&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=126&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) This section details the use of **$315.4 million** net proceeds from the July 2023 IPO for clinical trials and R&D, with no material change - On July 18, 2023, the company completed its IPO, receiving net proceeds of approximately **$315.4 million**[447](index=447&type=chunk)[449](index=449&type=chunk) - The net proceeds are being used to fund clinical trials and manufacturing for APG777, APG808, and APG990, as well as other R&D activities and general corporate purposes[450](index=450&type=chunk)[452](index=452&type=chunk) - There has been no material change in the intended use of proceeds from the IPO as described in the prospectus[452](index=452&type=chunk) [Defaults Upon Senior Securities](index=128&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) No defaults upon senior securities are reported - No defaults upon senior securities are reported[453](index=453&type=chunk) [Mine Safety Disclosures](index=128&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company - This item is not applicable to the company[454](index=454&type=chunk) [Other Information](index=128&type=section&id=Item%205.%20Other%20Information) No directors or executive officers adopted, modified, or terminated Rule 10b5-1 trading plans during Q2 2024 - During the three months ended June 30, 2024, none of the Company's directors or executive officers adopted, modified or terminated any trading plan under Rule 10b5-1(c)[455](index=455&type=chunk) [Exhibits](index=129&type=section&id=Item%206.%20Exhibits) This section lists exhibits filed with the Quarterly Report on Form 10-Q, including stock plan amendments, license agreements, and officer certifications - The report includes several exhibits, such as amendments to the 2023 Employee Stock Purchase Plan, license agreements with MIL 6T, LLC, and certifications by the CEO and CFO[458](index=458&type=chunk)
NewAmsterdam Pharma Announces Appointments of Mark C. McKenna and Wouter Joustra to its Board of Directors
Newsfilter· 2024-07-18 12:00
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]
Apogee Therapeutics: Infrequent Dosing Advantage In Biotech Play
Seeking Alpha· 2024-06-18 14:05
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]
Apogee Therapeutics Expands Board of Directors with the Appointment of Lisa Bollinger, MD
Newsfilter· 2024-05-28 11:30
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]
Apogee Therapeutics to Participate in Upcoming June Investor Conferences
Newsfilter· 2024-05-23 11:30
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 ...
Apogee Announces Dosing of First Patient in Phase 2 Atopic Dermatitis Trial of APG777, a Novel Subcutaneous Half-life Extended Anti-IL-13 Antibody for the Treatment of Atopic Dermatitis and Other Inflammatory Diseases
Newsfilter· 2024-05-15 20:01
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 ...
Apogee Therapeutics(APGE) - 2024 Q1 - Quarterly Report
2024-05-13 11:10
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 ...
Earnings Superstars: 3 Stocks Primed to Outperform This Quarter
InvestorPlace· 2024-05-08 17:28
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 ...
Apogee Therapeutics, Inc. Announces Closing of Upsized Public Offering and Full Exercise of the Underwriters' Option to Purchase Additional Shares for Gross Proceeds of $483 Million
Newsfilter· 2024-03-12 20:01
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]