Key Metrics

Market Cap	2.23B
Total Shares Outstanding	44.60M
Book Value	12.35
PE Ratio	-

PS Ratio	-
PB Ratio	3.11
Forward PE Ratio	-
ROIC	-

Return on Aseets	-23.46
Return on Equity	-33.22
Dividend	-
Dividend Yield	-

Balancesheet Metrics

Total Assets
Total Liability
Assets-to-Libability Ratio

Total Current Assets
Total Current Liability
Current Ratio

Quick Ratio
Debt to Equity Ratio

Income Statement Metrics

Net Income	-
EPS	-3.3
EBITA	-

Gross Profit	-
Gross Profit Margin	-
Operating Margin	-

Net Profit Margin

Price Metrics

5 Days MA	38.16
10 Days MA	35.09
20 Days MA	34.45
50 Days MA	38.66
200 Days MA	45.93

52 Weeks High	71.75
52 Weeks low	29.1
All Time High	72.29

RSI	56.09
MACD	-

Share Stats

Shares Float	39.06M
Shares Short	8.32M

% Short	0.1948%
% Insider	11.365%

% Institutions	130.158%

% Institutions

130.158%

News

Apogee Therapeutics' Investigational Atopic Dermatitis Potential Shows Strong Tolerability, Extended Half-Life in Early TrialOn Monday, Apogee Therapeutics, Inc. (NASDAQ:APGE) released interim Phase 1 results from its first-in-human trial of APG990. APG990 interim Phase 1 pharmacokinetic (PK) data showed a half-life of approximately 60 days across doses tested. Key data from the 40-healthy subject trial showed: APG990 ...
On Monday, Apogee Therapeutics, Inc. (NASDAQ:APGE) released interim Phase 1 results from its first-in-human trial of APG990. APG990 interim Phase 1 pharmacokinetic (PK) data showed a half-life of approximately 60 days across doses tested. Key data from the 40-healthy subject trial showed: APG990 demonstrated a potential best-in-class PK profile, including a half-life of approximately 60 days, supporting the potential for every three- and six-month maintenance dosing. The PK profile supports the potential for a single 2 mL co-formulated injection of APG279 (APG777 + APG990) administered every three and six months. APG990 was well tolerated across all five cohorts, with doses up to 1,200mg. The most common (≥10%) treatment-emergent adverse events (TEAEs) were headache.53% of participants observed at least one TEAE. There were no Grade 3 TEAEs related to the study drug or severe adverse events. No adverse events led to study discontinuation. There have been no cases of pyrexia or chills. In addition, preclinical studies of the combination of APG777 and APG990 showed potential for enhanced pharmacologic responses relative to individual agents and exhibited no safety findings at any dose level, including the highest dose tested of 150 mg/kg per agent in a 3-month combination toxicology study. The company plans to submit an Investigational New Drug application or foreign equivalent for APG279. Following clearance, the company plans to initiate a Phase 1b clinical trial in moderate-to-severe atopic dermatitis (AD) of APG279 against Sanofi SA (NASDAQ:SNY) / Regeneron Pharmaceuticals Inc’s (NASDAQ:REGN) Dupixent (dupilumab) in 2025, with data expected in the second half of 2026. The company says cash, cash equivalents, and marketable securities were $731.1 million as of December 31, 2024. Based on current operating plans, Apogee expects its existing cash, cash equivalents, and marketable securities will enable the company to fund its operating expenses into the first quarter of 2028. Price Action: APGE stock is up 7.14% at $33.68 at the last check Monday. Read Next: AST SpaceMobile Teams Up with Vodafone For Satellite Broadband Service Across Europe UNLOCKED: 5 NEW TRADES EVERY WEEK. Click now to get top trade ideas daily, plus unlimited access to cutting-edge tools and strategies to gain an edge in the markets. Get the latest stock analysis from Benzinga? This article Apogee Therapeutics' Investigational Atopic Dermatitis Potential Shows Strong Tolerability, Extended Half-Life in Early Trial originally appeared on Benzinga.com © 2025 Benzinga.com. Benzinga does not provide investment advice. All rights reserved. View Comments
APGE REGN SNY | finance.yahoo | about 10 days ago | Neutral

Apogee Therapeutics Provides Pipeline Progress and Reports Full Year 2024 Financial ResultsAccelerated execution of Phase 2 APEX clinical trial for APG777, with Part A over-enrolled and Part B initiated ahead of schedule; topline Part A 16-week data expected mid-2025 APG279 (APG777 + APG990) Phase 1b head-to-head study vs. DUPIXENT supported by positive APG990 interim Phase 1 results, wh...
Accelerated execution of Phase 2 APEX clinical trial for APG777, with Part A over-enrolled and Part B initiated ahead of schedule; topline Part A 16-week data expected mid-2025 APG279 (APG777 + APG990) Phase 1b head-to-head study vs. DUPIXENT supported by positive APG990 interim Phase 1 results, which exceeded trial objectives and demonstrated potential for three- and six-month dosing in combination with APG777; APG279 readout expected in second half of 2026 $731.1 million cash, cash equivalents and marketable securities with runway into Q1 2028 SAN FRANCISCO and BOSTON, March 03, 2025 (GLOBE NEWSWIRE) -- Apogee Therapeutics, Inc. (Nasdaq: APGE), a clinical-stage biotechnology company advancing novel biologics with the potential for differentiated efficacy and dosing in the largest inflammatory and immunology (I&I) markets, including for the treatment of atopic dermatitis (AD), asthma, eosinophilic esophagitis (EoE), chronic obstructive pulmonary disease (COPD) and other I&I indications, today provided pipeline progress and reported full year 2024 financial results. “We achieved significant progress across our pipeline in 2024 and are well-positioned to continue executing rapidly on our mission to bring transformative, potentially best-in-class therapies to patients with I&I diseases,” said Michael Henderson, M.D., Chief Executive Officer of Apogee. “We kicked off 2025 by over-enrolling Part A and dosing the first patient in the Part B portion of our Phase 2 APEX clinical trial for APG777 in AD, well ahead of schedule and we are on track for our critical 16-week readout for APG777 in mid-2025. Our positive readout today from the Phase 1 trial of APG990 in healthy volunteers enables our combination study of APG777 + APG990, which we have named APG279, versus DUPIXENT this year following regulatory submissions, with this important dataset expected in the second half of 2026. With a strong cash position and several meaningful catalysts expected, we are looking forward to an exciting and productive 2025.” Pipeline Highlights and Upcoming Milestones Company continues to execute on APG777 monotherapy program in AD as well as initial expansion indications in asthma and EoE: APG777 is a novel, subcutaneous (SQ), extended half-life monoclonal antibody (mAb) targeting IL-13 – a critical cytokine in inflammation and a primary driver of AD. At its December 2024 R&D Day, the company reported updated data from its Phase 1 APG777 trial, out to 12 months, including a half-life of 77 days, which continue to support a potentially best-in-class profile. In the updated dataset, safety was consistent with prior results, and APG777 demonstrated a favorable pharmacodynamic (PD) profile showing near complete inhibition of pSTAT6 for up to 12 months after a single administration and sustained TARC inhibition.The data support Apogee’s ongoing Phase 2 clinical trial of APG777 in AD and support the potential for improved clinical responses from greater exposures in induction and maintenance dosing of every three- and six-months. In February 2025, the company announced that Part A of the trial had exceeded enrollment expectations and the first patient was dosed in Part B – both milestones completed ahead of schedule. The company expects to report 16-week topline data from the Part A portion of the trial mid-2025.Apogee plans to initiate a Phase 1b trial in asthma the first half of 2025 followed by a Phase 2b trial in asthma in the second half of 2025 with data expected in 2026.The company also plans to initiate a Phase 2 trial in EoE in 2026. APG279 (APG777 + APG990) Phase 1b head-to-head study against DUPIXENT now supported by positive, interim Phase 1 results for APG990 and completion of a combination toxicology study: APG990 is a novel, SQ, half-life extended monoclonal antibody (mAb), and the combination with APG777 offers the potential for improved clinical responses over monotherapy across a variety of I&I diseases while Apogee’s approach of coformulating two extended half-life mAbs holds the potential for best-in-class dosing. Today, the company reported positive interim results in the Phase 1 first-in-human study of APG990, which is designed to evaluate the safety, tolerability, and pharmacokinetics (PK) of single-ascending doses (SAD) of APG990 in healthy volunteers. Key findings from the study include: PK profile includes half-life of approximately 60 days; PK profile supports the potential for a single 2 mL co-formulated injection of APG279 administered every three- and six-months in maintenance.APG990 was well tolerated across all dose groups with a favorable safety profile.Based on these data, Apogee plans to initiate its first combination trial in 2025 – a Phase 1b trial designed to evaluate the safety, PK, PD and efficacy of APG279 against DUPIXENT in patients with moderate-to-severe AD, with interim readout expected in the second half of 2026. Progress in respiratory indications continues with planned combination approach of APG777 + APG333: APG333 is a novel, SQ extended half-life mAb targeting thymic stromal lymphopoietin (TSLP), a key driver of Type 2 and Type 3 inflammation in eosinophilic and non-eosinophilic conditions. A Phase 1 trial of APG333 in healthy volunteers is underway, with data expected in the second half of 2025.Apogee plans to evaluate APG777 and APG333 monotherapies in respective Phase 1b trials in patients with asthma in 2025 to support advancement into future combination trials in asthma and COPD. Positive interim data for APG808 Phase 1 trial reported, supporting the potential for two- to three-month dosing and demonstrating deep and sustained inhibition of biomarkers: APG808 is a novel SQ extended half-life mAb targeting IL-4Rα, a target with clinical validation across eight Type 2 allergic diseases. APG808 has similar binding affinity for IL-4Rα as a first generation mAb, DUPIXENT, and has demonstrated similar inhibition to DUPIXENT across three in vitro assays that measure downstream functional inhibition of the IL-13/IL-4 pathway. At its December 2024 R&D Day, the company reported interim data from all four SAD cohorts in the Phase 1 healthy volunteer trial. APG808 demonstrated a potential best-in-class PK profile, including a half-life of approximately 55 days, and single doses of APG808 demonstrated deep and sustained effect on PD markers out to ~3 months (which was the longest follow-up available at the time of data cut). APG808 was well tolerated in the study.Apogee is also evaluating APG808 in a Phase 1b trial in patients with asthma, with data expected in the first half of 2025. Full Year 2024 Financial Results Cash Position: Cash, cash equivalents and marketable securities were $731.1 million as of December 31, 2024, compared to $395.5 million as of December 31, 2023. Based on current operating plans, Apogee expects its existing cash, cash equivalents and marketable securities will enable the company to fund its operating expenses into the first quarter of 2028. R&D Expenses: Research and development (R&D) expenses were $167.9 million for the year ended December 31, 2024, compared to $68.4 million for the year ended December 31, 2023. R&D expenses increased primarily due to continued development of the company’s APG777, APG990/APG777 + APG990, and APG333/APG777 + APG333 programs and advancement of its pipeline into clinical trials, as well as increases in personnel related expenses including equity-based compensation expense, associated with the growth of its R&D team. G&A Expenses: General and administrative (G&A) expenses were $49.0 million for the year ended December 31, 2024, compared to $24.6 million for the year ended December 31, 2023. G&A expenses increased primarily due to increases in personnel related expenses including equity-based compensation expenses, primarily driven by increased headcount and an increase in the fair value of equity awards granted. These increases are the result of the company’s expansion of operations to support the growth in its business and the costs of operating as a public entity. Net Loss: Net loss was $182.1 million for the year ended December 31, 2024, compared to a net loss of $84.0 million for the year ended December 31, 2023. Net loss increased primarily as a result of higher R&D and G&A expenses as described above, partially offset by higher interest income. About Apogee Apogee Therapeutics is a clinical-stage biotechnology company advancing novel biologics with potential for differentiated efficacy and dosing in the largest I&I markets, including for the treatment of AD, asthma, EoE, COPD and other I&I indications. Apogee’s antibody programs are designed to overcome limitations of existing therapies by targeting well-established mechanisms of action and incorporating advanced antibody engineering to optimize half-life and other properties. APG777, the company’s most advanced program, is being initially developed for the treatment of AD, which is the largest and one of the least penetrated I&I markets. With four validated targets in its portfolio, Apogee is seeking to achieve best-in-class efficacy and dosing through monotherapies and combinations of its novel antibodies. Based on a broad pipeline and depth of expertise, the company believes it can deliver value and meaningful benefit to patients underserved by today’s standard of care. For more information, please visit https://apogeetherapeutics.com. Forward Looking Statements Certain statements in this press release may constitute “forward-looking statements” within the meaning of the federal securities laws, including, but not limited to, statements regarding: Apogee’s plans for its current and future product candidates and programs; the anticipated timing of the initiation of its clinical trials, including the Phase 1b trial of APG279 (the combination of APG777 and APG990), the Phase 1b and 2b trials of APG777 in asthma, the Phase 2 trial of APG777 in EoE, and the Phase 1b trial of APG333 in asthma; the expected timing of and results from its clinical trials, including data from its Phase 2 trial of APG777, Phase 1b trial of APG279, Phase 1 trial of APG333, Phase 1b trial of APG808, the potential combination of APG777 and APG333; planned clinical trial designs; its plans for current and future clinical trials; the potential clinical benefit and half-life of APG777, APG990, APG333, APG808, Apogee’s other product candidates, including combination therapies, and any other potential programs; its expected timing for future pipeline updates and expectations regarding the time period over which Apogee’s capital resources will be sufficient to funds its anticipated operations. Words such as “may,” “might,” “will,” “objective,” “intend,” “should,” “could,” “can,” “would,” “expect,” “believe,” “design,” “estimate,” “predict,” “potential,” “develop,” “plan” or the negative of these terms, and similar expressions, or statements regarding intent, belief, or current expectations, are forward-looking statements. While Apogee believes these forward-looking statements are reasonable, undue reliance should not be placed on any such forward-looking statements, which are based on information available to the company on the date of this release. These forward-looking statements are based upon current estimates and assumptions and are subject to various risks and uncertainties (including, without limitation, those set forth in Apogee’s filings with the U.S. Securities and Exchange Commission (the SEC)), many of which are beyond the company’s control and subject to change. Actual results could be materially different. Risks and uncertainties include: global macroeconomic conditions and related volatility, expectations regarding the initiation, progress, and expected results of Apogee’s preclinical studies, clinical trials and research and development programs; expectations regarding the timing, completion and outcome of Apogee’s clinical trials; the unpredictable relationship between preclinical study results and clinical study results; the timing or likelihood of regulatory filings and approvals; liquidity and capital resources; and other risks and uncertainties identified in Apogee’s Quarterly Report on 10-Q for the quarterly period ended September 30, 2024, filed with the SEC on November 12, 2024, and subsequent disclosure documents the company may file with the SEC. Apogee claims the protection of the Safe Harbor contained in the Private Securities Litigation Reform Act of 1995 for forward-looking statements. Apogee expressly disclaims any obligation to update or alter any statements whether as a result of new information, future events or otherwise, except as required by law. APOGEE THERAPEUTICS, INC. CONSOLIDATED BALANCE SHEETS (In thousands, except unit/share data) DECEMBER 31, 2024 DECEMBER 31, 2023 Assets Current assets: Cash and cash equivalents $141,789 $118,316 Marketable securities 378,864 277,143 Prepaid expenses and other current assets 9,060 2,950 Total current assets 529,713 398,409 Long-term marketable securities 210,416 — Property and equipment, net 1,959 377 Right-of-use asset, net 11,365 2,217 Other non-current assets 498 401 Total assets $753,951 $401,404 Liabilities and stockholders' equity Current liabilities: Accounts payable $1,071 $2,143 Lease liability 3,234 1,101 Accrued expenses 24,255 17,314 Total current liabilities 28,560 20,558 Long-term liabilities: Lease liability, net of current 8,597 933 Total liabilities 37,157 21,491 Stockholders' equity: Common Stock; $0.00001 par value, 400,000,000 authorized, 59,478,725 issued and 58,062,898 outstanding as of December 31, 2024; 400,000,000 authorized, 50,655,671 issued and 48,338,769 outstanding as of December 31, 2023 1 — Additional paid-in capital 1,021,794 503,354 Accumulated other comprehensive income 915 329 Accumulated deficit (305,916) (123,770)Total stockholders’ equity 716,794 379,913 Total liabilities and stockholders’ equity $753,951 $401,404 APOGEE THERAPEUTICS, INC. CONSOLIDATED STATEMENTS OF OPERATIONS (In thousands) YEAR ENDED DECEMBER 31, 2024 2023 Operating expenses: Research and development $167,865 $68,424 General and administrative 49,005 24,579 Total operating expenses 216,870 93,003 Loss from operations (216,870) (93,003)Other income, net: Interest income, net 34,742 9,018 Total other income, net 34,742 9,018 Net loss before taxes (182,128) (83,985)Provision for income taxes (18) — Net loss after taxes $(182,146) $(83,985) Investor Contact: Noel Kurdi VP, Investor Relations Apogee Therapeutics, Inc. Noel.Kurdi@apogeetherapeutics.com Media Contact: Dan Budwick 1AB Media dan@1abmedia.com
APGE | globenewswire | about 11 days ago | Neutral

Apogee Therapeutics Provides Pipeline Progress and Reports Full Year 2024 Financial ResultsApogee Therapeutics Accelerated execution of Phase 2 APEX clinical trial for APG777, with Part A over-enrolled and Part B initiated ahead of schedule; topline Part A 16-week data expected mid-2025 APG279 (APG777 + APG990) Phase 1b head-to-head study vs. DUPIXENT supported by positive APG990 interi...
Apogee Therapeutics Accelerated execution of Phase 2 APEX clinical trial for APG777, with Part A over-enrolled and Part B initiated ahead of schedule; topline Part A 16-week data expected mid-2025 APG279 (APG777 + APG990) Phase 1b head-to-head study vs. DUPIXENT supported by positive APG990 interim Phase 1 results, which exceeded trial objectives and demonstrated potential for three- and six-month dosing in combination with APG777; APG279 readout expected in second half of 2026 $731.1 million cash, cash equivalents and marketable securities with runway into Q1 2028 SAN FRANCISCO and BOSTON, March 03, 2025 (GLOBE NEWSWIRE) -- Apogee Therapeutics, Inc. (Nasdaq: APGE), a clinical-stage biotechnology company advancing novel biologics with the potential for differentiated efficacy and dosing in the largest inflammatory and immunology (I&I) markets, including for the treatment of atopic dermatitis (AD), asthma, eosinophilic esophagitis (EoE), chronic obstructive pulmonary disease (COPD) and other I&I indications, today provided pipeline progress and reported full year 2024 financial results. “We achieved significant progress across our pipeline in 2024 and are well-positioned to continue executing rapidly on our mission to bring transformative, potentially best-in-class therapies to patients with I&I diseases,” said Michael Henderson, M.D., Chief Executive Officer of Apogee. “We kicked off 2025 by over-enrolling Part A and dosing the first patient in the Part B portion of our Phase 2 APEX clinical trial for APG777 in AD, well ahead of schedule and we are on track for our critical 16-week readout for APG777 in mid-2025. Our positive readout today from the Phase 1 trial of APG990 in healthy volunteers enables our combination study of APG777 + APG990, which we have named APG279, versus DUPIXENT this year following regulatory submissions, with this important dataset expected in the second half of 2026. With a strong cash position and several meaningful catalysts expected, we are looking forward to an exciting and productive 2025.” Pipeline Highlights and Upcoming Milestones Company continues to execute on APG777 monotherapy program in AD as well as initial expansion indications in asthma and EoE: APG777 is a novel, subcutaneous (SQ), extended half-life monoclonal antibody (mAb) targeting IL-13 – a critical cytokine in inflammation and a primary driver of AD. At its December 2024 R&D Day, the company reported updated data from its Phase 1 APG777 trial, out to 12 months, including a half-life of 77 days, which continue to support a potentially best-in-class profile. In the updated dataset, safety was consistent with prior results, and APG777 demonstrated a favorable pharmacodynamic (PD) profile showing near complete inhibition of pSTAT6 for up to 12 months after a single administration and sustained TARC inhibition. The data support Apogee’s ongoing Phase 2 clinical trial of APG777 in AD and support the potential for improved clinical responses from greater exposures in induction and maintenance dosing of every three- and six-months. In February 2025, the company announced that Part A of the trial had exceeded enrollment expectations and the first patient was dosed in Part B – both milestones completed ahead of schedule. The company expects to report 16-week topline data from the Part A portion of the trial mid-2025. Apogee plans to initiate a Phase 1b trial in asthma the first half of 2025 followed by a Phase 2b trial in asthma in the second half of 2025 with data expected in 2026. The company also plans to initiate a Phase 2 trial in EoE in 2026. Story Continues APG279 (APG777 + APG990) Phase 1b head-to-head study against DUPIXENT now supported by positive, interim Phase 1 results for APG990 and completion of a combination toxicology study: APG990 is a novel, SQ, half-life extended monoclonal antibody (mAb), and the combination with APG777 offers the potential for improved clinical responses over monotherapy across a variety of I&I diseases while Apogee’s approach of coformulating two extended half-life mAbs holds the potential for best-in-class dosing. Today, the company reported positive interim results in the Phase 1 first-in-human study of APG990, which is designed to evaluate the safety, tolerability, and pharmacokinetics (PK) of single-ascending doses (SAD) of APG990 in healthy volunteers. Key findings from the study include: PK profile includes half-life of approximately 60 days; PK profile supports the potential for a single 2 mL co-formulated injection of APG279 administered every three- and six-months in maintenance. APG990 was well tolerated across all dose groups with a favorable safety profile. Based on these data, Apogee plans to initiate its first combination trial in 2025 – a Phase 1b trial designed to evaluate the safety, PK, PD and efficacy of APG279 against DUPIXENT in patients with moderate-to-severe AD, with interim readout expected in the second half of 2026. Progress in respiratory indications continues with planned combination approach of APG777 + APG333: APG333 is a novel, SQ extended half-life mAb targeting thymic stromal lymphopoietin (TSLP), a key driver of Type 2 and Type 3 inflammation in eosinophilic and non-eosinophilic conditions. A Phase 1 trial of APG333 in healthy volunteers is underway, with data expected in the second half of 2025. Apogee plans to evaluate APG777 and APG333 monotherapies in respective Phase 1b trials in patients with asthma in 2025 to support advancement into future combination trials in asthma and COPD. Positive interim data for APG808 Phase 1 trial reported, supporting the potential for two- to three-month dosing and demonstrating deep and sustained inhibition of biomarkers: APG808 is a novel SQ extended half-life mAb targeting IL-4Rα, a target with clinical validation across eight Type 2 allergic diseases. APG808 has similar binding affinity for IL-4Rα as a first generation mAb, DUPIXENT, and has demonstrated similar inhibition to DUPIXENT across three in vitro assays that measure downstream functional inhibition of the IL-13/IL-4 pathway. At its December 2024 R&D Day, the company reported interim data from all four SAD cohorts in the Phase 1 healthy volunteer trial. APG808 demonstrated a potential best-in-class PK profile, including a half-life of approximately 55 days, and single doses of APG808 demonstrated deep and sustained effect on PD markers out to ~3 months (which was the longest follow-up available at the time of data cut). APG808 was well tolerated in the study. Apogee is also evaluating APG808 in a Phase 1b trial in patients with asthma, with data expected in the first half of 2025. Full Year 2024 Financial Results Cash Position: Cash, cash equivalents and marketable securities were $731.1 million as of December 31, 2024, compared to $395.5 million as of December 31, 2023. Based on current operating plans, Apogee expects its existing cash, cash equivalents and marketable securities will enable the company to fund its operating expenses into the first quarter of 2028. R&D Expenses: Research and development (R&D) expenses were $167.9 million for the year ended December 31, 2024, compared to $68.4 million for the year ended December 31, 2023. R&D expenses increased primarily due to continued development of the company’s APG777, APG990/APG777 + APG990, and APG333/APG777 + APG333 programs and advancement of its pipeline into clinical trials, as well as increases in personnel related expenses including equity-based compensation expense, associated with the growth of its R&D team. G&A Expenses: General and administrative (G&A) expenses were $49.0 million for the year ended December 31, 2024, compared to $24.6 million for the year ended December 31, 2023. G&A expenses increased primarily due to increases in personnel related expenses including equity-based compensation expenses, primarily driven by increased headcount and an increase in the fair value of equity awards granted. These increases are the result of the company’s expansion of operations to support the growth in its business and the costs of operating as a public entity. Net Loss: Net loss was $182.1 million for the year ended December 31, 2024, compared to a net loss of $84.0 million for the year ended December 31, 2023. Net loss increased primarily as a result of higher R&D and G&A expenses as described above, partially offset by higher interest income. About Apogee Apogee Therapeutics is a clinical-stage biotechnology company advancing novel biologics with potential for differentiated efficacy and dosing in the largest I&I markets, including for the treatment of AD, asthma, EoE, COPD and other I&I indications. Apogee’s antibody programs are designed to overcome limitations of existing therapies by targeting well-established mechanisms of action and incorporating advanced antibody engineering to optimize half-life and other properties. APG777, the company’s most advanced program, is being initially developed for the treatment of AD, which is the largest and one of the least penetrated I&I markets. With four validated targets in its portfolio, Apogee is seeking to achieve best-in-class efficacy and dosing through monotherapies and combinations of its novel antibodies. Based on a broad pipeline and depth of expertise, the company believes it can deliver value and meaningful benefit to patients underserved by today’s standard of care. For more information, please visit https://apogeetherapeutics.com. Forward Looking Statements Certain statements in this press release may constitute “forward-looking statements” within the meaning of the federal securities laws, including, but not limited to, statements regarding: Apogee’s plans for its current and future product candidates and programs; the anticipated timing of the initiation of its clinical trials, including the Phase 1b trial of APG279 (the combination of APG777 and APG990), the Phase 1b and 2b trials of APG777 in asthma, the Phase 2 trial of APG777 in EoE, and the Phase 1b trial of APG333 in asthma; the expected timing of and results from its clinical trials, including data from its Phase 2 trial of APG777, Phase 1b trial of APG279, Phase 1 trial of APG333, Phase 1b trial of APG808, the potential combination of APG777 and APG333; planned clinical trial designs; its plans for current and future clinical trials; the potential clinical benefit and half-life of APG777, APG990, APG333, APG808, Apogee’s other product candidates, including combination therapies, and any other potential programs; its expected timing for future pipeline updates and expectations regarding the time period over which Apogee’s capital resources will be sufficient to funds its anticipated operations. Words such as “may,” “might,” “will,” “objective,” “intend,” “should,” “could,” “can,” “would,” “expect,” “believe,” “design,” “estimate,” “predict,” “potential,” “develop,” “plan” or the negative of these terms, and similar expressions, or statements regarding intent, belief, or current expectations, are forward-looking statements. While Apogee believes these forward-looking statements are reasonable, undue reliance should not be placed on any such forward-looking statements, which are based on information available to the company on the date of this release. These forward-looking statements are based upon current estimates and assumptions and are subject to various risks and uncertainties (including, without limitation, those set forth in Apogee’s filings with the U.S. Securities and Exchange Commission (the SEC)), many of which are beyond the company’s control and subject to change. Actual results could be materially different. Risks and uncertainties include: global macroeconomic conditions and related volatility, expectations regarding the initiation, progress, and expected results of Apogee’s preclinical studies, clinical trials and research and development programs; expectations regarding the timing, completion and outcome of Apogee’s clinical trials; the unpredictable relationship between preclinical study results and clinical study results; the timing or likelihood of regulatory filings and approvals; liquidity and capital resources; and other risks and uncertainties identified in Apogee’s Quarterly Report on 10-Q for the quarterly period ended September 30, 2024, filed with the SEC on November 12, 2024, and subsequent disclosure documents the company may file with the SEC. Apogee claims the protection of the Safe Harbor contained in the Private Securities Litigation Reform Act of 1995 for forward-looking statements. Apogee expressly disclaims any obligation to update or alter any statements whether as a result of new information, future events or otherwise, except as required by law. APOGEE THERAPEUTICS, INC. CONSOLIDATED BALANCE SHEETS (In thousands, except unit/share data) DECEMBER 31, 2024 DECEMBER 31, 2023 Assets Current assets: Cash and cash equivalents $ 141,789 $ 118,316 Marketable securities 378,864 277,143 Prepaid expenses and other current assets 9,060 2,950 Total current assets 529,713 398,409 Long-term marketable securities 210,416 — Property and equipment, net 1,959 377 Right-of-use asset, net 11,365 2,217 Other non-current assets 498 401 Total assets $ 753,951 $ 401,404 Liabilities and stockholders' equity Current liabilities: Accounts payable $ 1,071 $ 2,143 Lease liability 3,234 1,101 Accrued expenses 24,255 17,314 Total current liabilities 28,560 20,558 Long-term liabilities: Lease liability, net of current 8,597 933 Total liabilities 37,157 21,491 Stockholders' equity: Common Stock; $0.00001 par value, 400,000,000 authorized, 59,478,725 issued and 58,062,898 outstanding as of December 31, 2024; 400,000,000 authorized, 50,655,671 issued and 48,338,769 outstanding as of December 31, 2023 1 — Additional paid-in capital 1,021,794 503,354 Accumulated other comprehensive income 915 329 Accumulated deficit (305,916 ) (123,770 ) Total stockholders’ equity 716,794 379,913 Total liabilities and stockholders’ equity $ 753,951 $ 401,404 APOGEE THERAPEUTICS, INC. CONSOLIDATED STATEMENTS OF OPERATIONS (In thousands) YEAR ENDED DECEMBER 31, 2024 2023 Operating expenses: Research and development $ 167,865 $ 68,424 General and administrative 49,005 24,579 Total operating expenses 216,870 93,003 Loss from operations (216,870 ) (93,003 ) Other income, net: Interest income, net 34,742 9,018 Total other income, net 34,742 9,018 Net loss before taxes (182,128 ) (83,985 ) Provision for income taxes (18 ) — Net loss after taxes $ (182,146 ) $ (83,985 ) Investor Contact: Noel Kurdi VP, Investor Relations Apogee Therapeutics, Inc. Noel.Kurdi@apogeetherapeutics.com Media Contact: Dan Budwick 1AB Media dan@1abmedia.com View Comments
APGE | finance.yahoo | about 11 days ago | Neutral

Apogee Therapeutics Announces Positive Interim Phase 1 Results from the APG990 Healthy Volunteer Trial, Unlocking Potential Maintenance Dosing Every Three and Six Months for APG279 (APG777 + APG990)Interim Phase 1 results for APG990, a novel half-life extended OX40L antibody, exceeded trial objectives and demonstrated an approximately 60-day half-life APG279 (APG777 + APG990) Phase 1b head-to-head study vs. DUPIXENT supported by successful completion of preclinical combination toxicology stud...
Interim Phase 1 results for APG990, a novel half-life extended OX40L antibody, exceeded trial objectives and demonstrated an approximately 60-day half-life APG279 (APG777 + APG990) Phase 1b head-to-head study vs. DUPIXENT supported by successful completion of preclinical combination toxicology studies and positive APG990 interim Phase 1 results; trial planned to initiate this year with readout expected in second half of 2026 Webcast to be held today at 8:30 a.m. ET SAN FRANCISCO and BOSTON, March 03, 2025 (GLOBE NEWSWIRE) -- Apogee Therapeutics, Inc. (Nasdaq: APGE), a clinical-stage biotechnology company advancing novel biologics with potential for differentiated efficacy and dosing in the largest inflammatory and immunology (I&I) markets, including for the treatment of atopic dermatitis (AD), asthma, eosinophilic esophagitis (EoE), chronic obstructive pulmonary disease (COPD) and other I&I indications, today announced positive interim Phase 1 results from its first-in-human trial of APG990. APG990 interim Phase 1 pharmacokinetic (PK) data showed a half-life of approximately 60 days across doses tested. These PK data support the possibility of every three- and six-month maintenance dosing of APG990 with as little as 50 mg, which when considered with APG279 (APG777 + APG990) coformulation data, provides the potential for dosing the combination two to four times per year with a single 2 mL coformulated injection. The combination also offers the potential for improved clinical outcomes by addressing the heterogeneity of AD given preclinical data demonstrating deep Type 2 inhibition from APG777 and broad Type 1-3 inhibition from APG990. “We’re pleased to report findings from our third clinical program today, APG990, which demonstrated extended PK and a favorable tolerability profile, supporting its potential as a first-in-class combination with APG777 for the treatment of AD and other inflammatory diseases that could address multiple inflammation pathways,” said Michael Henderson, M.D., Chief Executive Officer of Apogee. “The interim results as well as the supportive preclinical combination toxicology studies are an important step forward in our combination plans for the program, suggesting strong potential for compatibility with APG777 and supporting our planned APG777 and APG990 coformulated combination approach, which we have named APG279. With the potential to broadly inhibit Type 1, Type 2 and Type 3 inflammation, APG279 could offer patients a more effective treatment option, while minimizing side effects seen with other available therapies. Based on these findings, we plan to initiate a head-to-head Phase 1b trial of the combination against DUPIXENT this year.” APG990 is a novel, subcutaneous (SQ), half-life-extended monoclonal antibody (mAb) that targets OX40L, which is positioned further upstream in the inflammatory pathway than IL-13, allowing for a broader impact on the inflammatory cascade by inhibiting Type 1, Type 2, and Type 3 pathways. Apogee’s approach of coformulating two extended half-life mAbs, APG279, holds the potential for best-in-class dosing and efficacy across AD and broader I&I diseases. The APG990 Phase 1 clinical trial is a double-blind, placebo-controlled, first-in-human, single-ascending dose trial evaluating the safety, tolerability and PK of APG990 in 40 healthy adult participants. Key results include: APG990 demonstrated a potential best-in-class PK profile, including a half-life of approximately 60 days, supporting the potential for every three- and six-month maintenance dosing. PK profile supports the potential for a single 2 mL coformulated injection of APG279 (APG777 + APG990) administered every three- and six- months.APG990 was well tolerated across all five cohorts, with doses up to 1,200mg. The most common (≥10%) treatment-emergent adverse events (TEAEs) were headache. 53% of participants observed at least one TEAE.There were no Grade 3 TEAEs related to study drug or severe adverse events. No adverse events led to study discontinuation. There have been no cases of pyrexia or chills. In addition, preclinical studies of the combination of APG777 and APG990 showed potential for enhanced pharmacologic responses relative to individual agents, and exhibited no safety findings at any dose level, including the highest dose tested of 150 mg/kg per agent in a 3-month combination toxicology study. “Today’s results are highly encouraging, further validating our approach to create fully optimized antibodies with the potential to improve patients’ lives. With good tolerability at doses up to 1,200mg and a half-life of approximately 60 days, APG990 demonstrated the potential for quarterly or less frequent dosing and was supportive of it as a combination partner with APG777. Looking ahead to our planned combination approach, we continue to believe that APG990’s broad inhibition across Type 1, 2, and 3 inflammation, coupled with APG777’s deep and sustained inhibition of Type 2 inflammation, could potentially result in a safe and effective treatment option for people living with atopic dermatitis and other inflammatory diseases,” said Carl Dambkowski, M.D., Chief Medical Officer of Apogee. “We would like to extend our gratitude to the participants, investigators, and site staff whose partnership made this study a success, driving progress toward innovative I&I treatments for patients in need.” Based on these results, the company plans on submitting an Investigational New Drug application or foreign equivalent for APG279. Following clearance, the company plans to initiate a Phase 1b clinical trial in moderate-to-severe AD of APG279 against DUPIXENT in 2025, with data expected in the second half of 2026. Webcast Details Apogee Therapeutics’ live webcast of the APG990 interim Phase 1 results will begin today at 8:30 a.m. ET. The live webcast can be accessed via this link or the Investors section on the Company’s website at https://investors.apogeetherapeutics.com/news-events/events. A replay of the webcast will be available following the call. About APG990 APG990 is a novel, SQ, half-life extended mAb targeting OX40L, initially being developed for AD. OX40L is located further upstream in the inflammatory pathway than IL-13 or IL-4Rα and targeting it could potentially have broader impact on the inflammatory cascade by inhibiting Type 1, Type 2 and Type 3 pathways. AD is a heterogeneous disease and varies by age, severity and ethnicity. With current approved biologics in AD only targeting the type 2 inflammatory pathway, OX40L could represent another therapeutic option for patients, especially the portion of patients who do not benefit from currently available treatments. In our head-to-head preclinical assays, APG990 has demonstrated similar or improved potency to amlitelimab. In addition, based on our interim Phase 1 APG990 studies, we believe APG990 can be dosed every three- and six- months in maintenance, which, if our clinical trials are successful, would represent a significant improvement compared to first generation OX40L antibodies that are expected to be dosed every four to twelve weeks. The company plans to develop APG279 (APG777 and APG990), together as a potential first-in-class combination for the treatment of AD and other I&I diseases by combining deep and sustained inhibition of Type 2 inflammation via APG777’s inhibition of IL-13 with broader inhibition of Type 1-3 inflammation through APG990’s inhibition of OX40L. About Apogee Apogee Therapeutics is a clinical-stage biotechnology company advancing novel biologics with potential for differentiated efficacy and dosing in the largest I&I markets, including for the treatment of AD, asthma, EoE, COPD and other I&I indications. Apogee’s antibody programs are designed to overcome limitations of existing therapies by targeting well-established mechanisms of action and incorporating advanced antibody engineering to optimize half-life and other properties. APG777, the company’s most advanced program, is being initially developed for the treatment of AD, which is the largest and one of the least penetrated I&I markets. With four validated targets in its portfolio, Apogee is seeking to achieve best-in-class efficacy and dosing through monotherapies and combinations of its novel antibodies. Based on a broad pipeline and depth of expertise, the company believes it can deliver value and meaningful benefit to patients underserved by today’s standard of care. For more information, please visit https://apogeetherapeutics.com. Forward Looking Statements Certain statements in this press release may constitute “forward-looking statements” within the meaning of the federal securities laws, including, but not limited to, statements regarding: Apogee’s plans for its current and future product candidates and programs; plans for and expected timing of regulatory filings, including the Investigational New Drug application for APG279 (the APG777 and APG990 combination); the anticipated timing of initiation of its Phase 1b clinical trial of the APG279; planned clinical trial designs; its plans for current and future clinical trials; the anticipated timing of results from its clinical trials, including data from its Phase 1b clinical trial of APG279 ; the potential clinical benefit, safety and half-life of APG777, APG990, and APG279, Apogee’s other product candidates, including combination therapies, and any other potential programs; programs; the potential dosing schedules for APG990 and APG279; and its expected timing for future pipeline updates. Words such as “may,” “might,” “will,” “objective,” “intend,” “should,” “could,” “can,” “would,” “expect,” “believe,” “design,” “estimate,” “predict,” “potential,” “develop,” “plan” or the negative of these terms, and similar expressions, or statements regarding intent, belief, or current expectations, are forward-looking statements. While Apogee believes these forward-looking statements are reasonable, undue reliance should not be placed on any such forward-looking statements, which are based on information available to the company on the date of this release. These forward-looking statements are based upon current estimates and assumptions and are subject to various risks and uncertainties (including, without limitation, those set forth in Apogee’s filings with the U.S. Securities and Exchange Commission (the SEC)), many of which are beyond the company’s control and subject to change. Actual results could be materially different. Risks and uncertainties include: global macroeconomic conditions and related volatility, expectations regarding the initiation, progress, and expected results of Apogee’s preclinical studies, clinical trials and research and development programs; expectations regarding the timing, completion and outcome of Apogee’s clinical trials; the unpredictable relationship between preclinical study results and clinical study results; the timing or likelihood of regulatory filings and approvals; liquidity and capital resources; and other risks and uncertainties identified in Apogee’s Quarterly Report on 10-Q for the quarterly period ended September 30, 2024, filed with the SEC on November 12, 2024, and subsequent disclosure documents Apogee may file with the SEC. Apogee claims the protection of the Safe Harbor contained in the Private Securities Litigation Reform Act of 1995 for forward-looking statements. Apogee expressly disclaims any obligation to update or alter any statements whether as a result of new information, future events or otherwise, except as required by law. Investor Contact: Noel Kurdi VP, Investor Relations Apogee Therapeutics, Inc. noel.kurdi@apogeetherapeutics.com Media Contact: Dan Budwick 1AB dan@1abmedia.com
APGE | globenewswire | about 11 days ago | Neutral

Apogee Therapeutics Announces Positive Interim Phase 1 Results from the APG990 Healthy Volunteer Trial, Unlocking Potential Maintenance Dosing Every Three and Six Months for APG279 (APG777 + APG990)Apogee Therapeutics Interim Phase 1 results for APG990, a novel half-life extended OX40L antibody, exceeded trial objectives and demonstrated an approximately 60-day half-life APG279 (APG777 + APG990) Phase 1b head-to-head study vs. DUPIXENT supported by successful completion of preclinical combin...
Apogee Therapeutics Interim Phase 1 results for APG990, a novel half-life extended OX40L antibody, exceeded trial objectives and demonstrated an approximately 60-day half-life APG279 (APG777 + APG990) Phase 1b head-to-head study vs. DUPIXENT supported by successful completion of preclinical combination toxicology studies and positive APG990 interim Phase 1 results; trial planned to initiate this year with readout expected in second half of 2026 Webcast to be held today at 8:30 a.m. ET SAN FRANCISCO and BOSTON, March 03, 2025 (GLOBE NEWSWIRE) -- Apogee Therapeutics, Inc. (Nasdaq: APGE), a clinical-stage biotechnology company advancing novel biologics with potential for differentiated efficacy and dosing in the largest inflammatory and immunology (I&I) markets, including for the treatment of atopic dermatitis (AD), asthma, eosinophilic esophagitis (EoE), chronic obstructive pulmonary disease (COPD) and other I&I indications, today announced positive interim Phase 1 results from its first-in-human trial of APG990. APG990 interim Phase 1 pharmacokinetic (PK) data showed a half-life of approximately 60 days across doses tested. These PK data support the possibility of every three- and six-month maintenance dosing of APG990 with as little as 50 mg, which when considered with APG279 (APG777 + APG990) coformulation data, provides the potential for dosing the combination two to four times per year with a single 2 mL coformulated injection. The combination also offers the potential for improved clinical outcomes by addressing the heterogeneity of AD given preclinical data demonstrating deep Type 2 inhibition from APG777 and broad Type 1-3 inhibition from APG990. “We’re pleased to report findings from our third clinical program today, APG990, which demonstrated extended PK and a favorable tolerability profile, supporting its potential as a first-in-class combination with APG777 for the treatment of AD and other inflammatory diseases that could address multiple inflammation pathways,” said Michael Henderson, M.D., Chief Executive Officer of Apogee. “The interim results as well as the supportive preclinical combination toxicology studies are an important step forward in our combination plans for the program, suggesting strong potential for compatibility with APG777 and supporting our planned APG777 and APG990 coformulated combination approach, which we have named APG279. With the potential to broadly inhibit Type 1, Type 2 and Type 3 inflammation, APG279 could offer patients a more effective treatment option, while minimizing side effects seen with other available therapies. Based on these findings, we plan to initiate a head-to-head Phase 1b trial of the combination against DUPIXENT this year.” Story Continues APG990 is a novel, subcutaneous (SQ), half-life-extended monoclonal antibody (mAb) that targets OX40L, which is positioned further upstream in the inflammatory pathway than IL-13, allowing for a broader impact on the inflammatory cascade by inhibiting Type 1, Type 2, and Type 3 pathways. Apogee’s approach of coformulating two extended half-life mAbs, APG279, holds the potential for best-in-class dosing and efficacy across AD and broader I&I diseases. The APG990 Phase 1 clinical trial is a double-blind, placebo-controlled, first-in-human, single-ascending dose trial evaluating the safety, tolerability and PK of APG990 in 40 healthy adult participants. Key results include: APG990 demonstrated a potential best-in-class PK profile, including a half-life of approximately 60 days, supporting the potential for every three- and six-month maintenance dosing. PK profile supports the potential for a single 2 mL coformulated injection of APG279 (APG777 + APG990) administered every three- and six- months. APG990 was well tolerated across all five cohorts, with doses up to 1,200mg. The most common (≥10%) treatment-emergent adverse events (TEAEs) were headache. 53% of participants observed at least one TEAE. There were no Grade 3 TEAEs related to study drug or severe adverse events. No adverse events led to study discontinuation. There have been no cases of pyrexia or chills. In addition, preclinical studies of the combination of APG777 and APG990 showed potential for enhanced pharmacologic responses relative to individual agents, and exhibited no safety findings at any dose level, including the highest dose tested of 150 mg/kg per agent in a 3-month combination toxicology study. “Today’s results are highly encouraging, further validating our approach to create fully optimized antibodies with the potential to improve patients’ lives. With good tolerability at doses up to 1,200mg and a half-life of approximately 60 days, APG990 demonstrated the potential for quarterly or less frequent dosing and was supportive of it as a combination partner with APG777. Looking ahead to our planned combination approach, we continue to believe that APG990’s broad inhibition across Type 1, 2, and 3 inflammation, coupled with APG777’s deep and sustained inhibition of Type 2 inflammation, could potentially result in a safe and effective treatment option for people living with atopic dermatitis and other inflammatory diseases,” said Carl Dambkowski, M.D., Chief Medical Officer of Apogee. “We would like to extend our gratitude to the participants, investigators, and site staff whose partnership made this study a success, driving progress toward innovative I&I treatments for patients in need.” Based on these results, the company plans on submitting an Investigational New Drug application or foreign equivalent for APG279. Following clearance, the company plans to initiate a Phase 1b clinical trial in moderate-to-severe AD of APG279 against DUPIXENT in 2025, with data expected in the second half of 2026. Webcast Details Apogee Therapeutics’ live webcast of the APG990 interim Phase 1 results will begin today at 8:30 a.m. ET. The live webcast can be accessed via this link or the Investors section on the Company’s website at https://investors.apogeetherapeutics.com/news-events/events. A replay of the webcast will be available following the call. About APG990 APG990 is a novel, SQ, half-life extended mAb targeting OX40L, initially being developed for AD. OX40L is located further upstream in the inflammatory pathway than IL-13 or IL-4Rα and targeting it could potentially have broader impact on the inflammatory cascade by inhibiting Type 1, Type 2 and Type 3 pathways. AD is a heterogeneous disease and varies by age, severity and ethnicity. With current approved biologics in AD only targeting the type 2 inflammatory pathway, OX40L could represent another therapeutic option for patients, especially the portion of patients who do not benefit from currently available treatments. In our head-to-head preclinical assays, APG990 has demonstrated similar or improved potency to amlitelimab. In addition, based on our interim Phase 1 APG990 studies, we believe APG990 can be dosed every three- and six- months in maintenance, which, if our clinical trials are successful, would represent a significant improvement compared to first generation OX40L antibodies that are expected to be dosed every four to twelve weeks. The company plans to develop APG279 (APG777 and APG990), together as a potential first-in-class combination for the treatment of AD and other I&I diseases by combining deep and sustained inhibition of Type 2 inflammation via APG777’s inhibition of IL-13 with broader inhibition of Type 1-3 inflammation through APG990’s inhibition of OX40L. About Apogee Apogee Therapeutics is a clinical-stage biotechnology company advancing novel biologics with potential for differentiated efficacy and dosing in the largest I&I markets, including for the treatment of AD, asthma, EoE, COPD and other I&I indications. Apogee’s antibody programs are designed to overcome limitations of existing therapies by targeting well-established mechanisms of action and incorporating advanced antibody engineering to optimize half-life and other properties. APG777, the company’s most advanced program, is being initially developed for the treatment of AD, which is the largest and one of the least penetrated I&I markets. With four validated targets in its portfolio, Apogee is seeking to achieve best-in-class efficacy and dosing through monotherapies and combinations of its novel antibodies. Based on a broad pipeline and depth of expertise, the company believes it can deliver value and meaningful benefit to patients underserved by today’s standard of care. For more information, please visit https://apogeetherapeutics.com. Forward Looking Statements Certain statements in this press release may constitute “forward-looking statements” within the meaning of the federal securities laws, including, but not limited to, statements regarding: Apogee’s plans for its current and future product candidates and programs; plans for and expected timing of regulatory filings, including the Investigational New Drug application for APG279 (the APG777 and APG990 combination); the anticipated timing of initiation of its Phase 1b clinical trial of the APG279; planned clinical trial designs; its plans for current and future clinical trials; the anticipated timing of results from its clinical trials, including data from its Phase 1b clinical trial of APG279 ; the potential clinical benefit, safety and half-life of APG777, APG990, and APG279, Apogee’s other product candidates, including combination therapies, and any other potential programs; programs; the potential dosing schedules for APG990 and APG279; and its expected timing for future pipeline updates. Words such as “may,” “might,” “will,” “objective,” “intend,” “should,” “could,” “can,” “would,” “expect,” “believe,” “design,” “estimate,” “predict,” “potential,” “develop,” “plan” or the negative of these terms, and similar expressions, or statements regarding intent, belief, or current expectations, are forward-looking statements. While Apogee believes these forward-looking statements are reasonable, undue reliance should not be placed on any such forward-looking statements, which are based on information available to the company on the date of this release. These forward-looking statements are based upon current estimates and assumptions and are subject to various risks and uncertainties (including, without limitation, those set forth in Apogee’s filings with the U.S. Securities and Exchange Commission (the SEC)), many of which are beyond the company’s control and subject to change. Actual results could be materially different. Risks and uncertainties include: global macroeconomic conditions and related volatility, expectations regarding the initiation, progress, and expected results of Apogee’s preclinical studies, clinical trials and research and development programs; expectations regarding the timing, completion and outcome of Apogee’s clinical trials; the unpredictable relationship between preclinical study results and clinical study results; the timing or likelihood of regulatory filings and approvals; liquidity and capital resources; and other risks and uncertainties identified in Apogee’s Quarterly Report on 10-Q for the quarterly period ended September 30, 2024, filed with the SEC on November 12, 2024, and subsequent disclosure documents Apogee may file with the SEC. Apogee claims the protection of the Safe Harbor contained in the Private Securities Litigation Reform Act of 1995 for forward-looking statements. Apogee expressly disclaims any obligation to update or alter any statements whether as a result of new information, future events or otherwise, except as required by law. Investor Contact: Noel Kurdi VP, Investor Relations Apogee Therapeutics, Inc. noel.kurdi@apogeetherapeutics.com Media Contact: Dan Budwick 1AB dan@1abmedia.com View Comments
APGE | finance.yahoo | about 11 days ago | Neutral

Is Apogee Therapeutics, Inc. (APGE) the Best Small-Cap Stock to Buy Now?We recently published a list of the 10 Best Small-Cap Stocks to Buy Now. In this article, we are going to take a look at where Apogee Therapeutics, Inc. (NASDAQ:APGE) stands against the other small-cap stocks. The S&P 500 index has reached its all-time highs, achieving returns of over 20% for the s...
We recently published a list of the 10 Best Small-Cap Stocks to Buy Now. In this article, we are going to take a look at where Apogee Therapeutics, Inc. (NASDAQ:APGE) stands against the other small-cap stocks. The S&P 500 index has reached its all-time highs, achieving returns of over 20% for the second consecutive year post-COVID. With the index hitting all-time highs, small-cap stocks can be a good option to explore with higher growth potential in the long term. However, the Russell 2000 small-cap index returned a little over 7% in 2024 compared to the 23% returns by the S&P 500. Over the past five years (through February 25, 2025), the S&P 500 has almost doubled the return of the Russell 2000 small cap, with returns of 102% against 47%, respectively. Small-Cap Stocks Prospects in 2025 On December 30, MJP Wealth Advisors chief investment officer Brian Vendig appeared on Yahoo! Finance’s Catalysts to address the potential outlook of small-cap stocks in 2025. Vendig said that a stable economy and policy will positively impact the small-caps, creating business expansion and merger opportunities. However, the Trump administration’s harsh tariff policies could impact the broader small-cap stocks as these companies contribute significantly to the U.S. domestic market. The role of the Fed will also be key in keeping the economy afloat. Vendig said that the market is expected to be choppy in the first few months of 2025. Businesses will start to progress in the second half of 2025 as the policies become clearer. However, Vendig believed that if earnings remain intact, he will likely stay constructive on stocks. He is also bullish on bonds, which might be a good opportunity as well. He said: “I’m definitely not one to recommend adding to mega-cap tech at this point, but I think taking a look at some of those value-oriented sectors that help to play into innovation and growth for the economy still makes sense.” With that said, let’s take a look at the Best Small-Cap Stock to Buy Now.Is Apogee Therapeutics, Inc. (NASDAQ:APGE) the Best Small-Cap Stock to Buy Now? A biotechnology research center with scientists wearing lab coats and goggles experimenting with single molecule sequencing. Our Methodology We used the Finviz stock screener to compile a list of 30 small-cap stocks. We then selected the top 10 best small-cap stocks based on hedge fund sentiment as of Q4 2024. We have used analyst upside, as of February 27, as a secondary metric to rank the stocks with the same number of hedge fund holders. The list is sorted in ascending order of number of hedge fund holders. Why are we interested in the stocks that hedge funds pile into? The reason is simple: our research has shown that we can outperform the market by imitating the top stock picks of the best hedge funds. Our quarterly newsletter’s strategy selects 14 small-cap and large-cap stocks every quarter and has returned 373.4% since May 2014, beating its benchmark by 218 percentage points (see more details here). Story Continues Apogee Therapeutics, Inc. (NASDAQ:APGE) Analyst Upside: 164.49% No. of Hedge Fund Holders: 31 Apogee Therapeutics, Inc. (NASDAQ:APGE) is a clinical-stage biotechnology company engaged in treating immunological and inflammatory diseases. The company has a wide portfolio and it has the potential to treat various dermatological, respiratory, and gastroenterological conditions. Apogee is making developments in the trials for key drugs, participating in crucial conferences, and revealing important updates from trials. On February 3, the company reported that the first patient was dosed in the Part B portion of Phase 2 of its clinical trial of APG777 in patients with moderate-to-severe AD. The company has also completed the enrollment of the same phase in the Part A portion of the trial. The Chief Medical Officer of Apogee, Carl Dambkowski, addressed the accelerated development of its APG777 trails and said: “Enrollment for the Phase 2 Part A trial of APG777 surpassed the approximately 110 patient target ahead of schedule, driven by strong patient and investigator enthusiasm, underscoring the potential of APG777 to address the need for safe, effective treatment options that reduce injection burden and provide better disease control for patients with AD and other I&I conditions.” During Q3 2024, Apogee Therapeutics, Inc. (NASDAQ:APGE) management mentioned that they are on track to release Phase 2 Part A data for APG777 in the second half of 2025. The company is also progressing on its APG333 trials, which have the potential to offer top-notch efficacy across several respiratory conditions, representing a solid feat for Apogee’s growth potential. By the end of Q3, the company had around $754 million in cash and cash equivalents, addressing its ability to operate smoothly into 2028. APGE is one of the emerging players in the biotech industry and the company plans to continue building its portfolio with transformative therapies. Overall, APGE ranks 9th on our list of best small-cap stocks to buy now. While we acknowledge the potential of APGE as an investment, our conviction lies in the belief that AI stocks hold greater promise for delivering higher returns and doing so within a shorter time frame. If you are looking for an AI stock that is more promising than APGE but that trades at less than 5 times its earnings, check out our report about the cheapest AI stock. READ NEXT: 20 Best AI Stocks To Buy Now and Complete List of 59 AI Companies Under $2 Billion in Market Cap Disclosure: None. This article is originally published at Insider Monkey. View Comments
APGE | finance.yahoo | about 13 days ago | Neutral

Apogee Therapeutics to Host Conference Call to Report Interim Results from the Phase 1 Healthy Volunteer Trial for APG990 and Provide Combination Strategy Update on March 3, 2025SAN FRANCISCO and BOSTON, Feb. 28, 2025 (GLOBE NEWSWIRE) -- Apogee Therapeutics, Inc., (Nasdaq: APGE), a clinical-stage biotechnology company advancing novel biologics with potential for differentiated efficacy and dosing in the largest inflammatory and immunology (I&I) markets, including for the ...
SAN FRANCISCO and BOSTON, Feb. 28, 2025 (GLOBE NEWSWIRE) -- Apogee Therapeutics, Inc., (Nasdaq: APGE), a clinical-stage biotechnology company advancing novel biologics with potential for differentiated efficacy and dosing in the largest inflammatory and immunology (I&I) markets, including for the treatment of atopic dermatitis (AD), asthma, eosinophilic esophagitis (EoE), chronic obstructive pulmonary disease (COPD) and other I&I indications, today announced it will report interim results from the Phase 1 APG990 healthy volunteer trial on Monday, March 3, 2025. Following the announcement, the Company will host a conference call and webcast at 8:30am ET to discuss the results and plans for its combination approach for APG777 + APG990. Webcast Details Apogee Therapeutics’ live webcast of the APG990 interim Phase 1 results will begin on Monday, March 3rd at 8:30 a.m. ET. The live webcast can be accessed via this link or the Investors section on the Company’s website at https://investors.apogeetherapeutics.com/news-events/events. A replay of the webcast will be available following the call. About Apogee Apogee Therapeutics is a clinical-stage biotechnology company advancing novel biologics with potential for differentiated efficacy and dosing in the largest I&I markets, including for the treatment of AD, asthma, EoE, COPD and other I&I indications. Apogee’s antibody programs are designed to overcome limitations of existing therapies by targeting well-established mechanisms of action and incorporating advanced antibody engineering to optimize half-life and other properties. APG777, the company’s most advanced program, is being initially developed for the treatment of AD, which is the largest and one of the least penetrated I&I markets. With four validated targets in its portfolio, Apogee is seeking to achieve best-in-class efficacy and dosing through monotherapies and combinations of its novel antibodies. Based on a broad pipeline and depth of expertise, the company believes it can deliver value and meaningful benefit to patients underserved by today’s standard of care. For more information, please visit https://apogeetherapeutics.com. Investor Contact: Noel Kurdi VP, Investor Relations Apogee Therapeutics, Inc. noel.kurdi@apogeetherapeutics.com Media Contact: Dan Budwick 1AB Media dan@1abmedia.com
APGE | globenewswire | about 13 days ago | Neutral

Apogee Therapeutics to Host Conference Call to Report Interim Results from the Phase 1 Healthy Volunteer Trial for APG990 and Provide Combination Strategy Update on March 3, 2025Apogee Therapeutics Webcast to be held Monday, March 3rd at 8:30 a.m. ET SAN FRANCISCO and BOSTON, Feb. 28, 2025 (GLOBE NEWSWIRE) -- Apogee Therapeutics, Inc., (Nasdaq: APGE), a clinical-stage biotechnology company advancing novel biologics with potential for differentiated efficacy and dosing in ...
Apogee Therapeutics Webcast to be held Monday, March 3rd at 8:30 a.m. ET SAN FRANCISCO and BOSTON, Feb. 28, 2025 (GLOBE NEWSWIRE) -- Apogee Therapeutics, Inc., (Nasdaq: APGE), a clinical-stage biotechnology company advancing novel biologics with potential for differentiated efficacy and dosing in the largest inflammatory and immunology (I&I) markets, including for the treatment of atopic dermatitis (AD), asthma, eosinophilic esophagitis (EoE), chronic obstructive pulmonary disease (COPD) and other I&I indications, today announced it will report interim results from the Phase 1 APG990 healthy volunteer trial on Monday, March 3, 2025. Following the announcement, the Company will host a conference call and webcast at 8:30am ET to discuss the results and plans for its combination approach for APG777 + APG990. Webcast Details Apogee Therapeutics’ live webcast of the APG990 interim Phase 1 results will begin on Monday, March 3rd at 8:30 a.m. ET. The live webcast can be accessed via this link or the Investors section on the Company’s website at https://investors.apogeetherapeutics.com/news-events/events. A replay of the webcast will be available following the call. About Apogee Apogee Therapeutics is a clinical-stage biotechnology company advancing novel biologics with potential for differentiated efficacy and dosing in the largest I&I markets, including for the treatment of AD, asthma, EoE, COPD and other I&I indications. Apogee’s antibody programs are designed to overcome limitations of existing therapies by targeting well-established mechanisms of action and incorporating advanced antibody engineering to optimize half-life and other properties. APG777, the company’s most advanced program, is being initially developed for the treatment of AD, which is the largest and one of the least penetrated I&I markets. With four validated targets in its portfolio, Apogee is seeking to achieve best-in-class efficacy and dosing through monotherapies and combinations of its novel antibodies. Based on a broad pipeline and depth of expertise, the company believes it can deliver value and meaningful benefit to patients underserved by today’s standard of care. For more information, please visit https://apogeetherapeutics.com. Investor Contact: Noel Kurdi VP, Investor Relations Apogee Therapeutics, Inc. noel.kurdi@apogeetherapeutics.com Media Contact: Dan Budwick 1AB Media dan@1abmedia.com View Comments
APGE | finance.yahoo | about 13 days ago | Neutral

Apogee Therapeutics to Participate in Upcoming March Investor ConferencesSAN FRANCISCO and BOSTON, Feb. 25, 2025 (GLOBE NEWSWIRE) -- Apogee Therapeutics, Inc., (Nasdaq: APGE) today announced that members of management will participate at the following investor conferences. TD Cowen 45th Annual Health Care Conference Date: Tuesday, March 4, 2025 Time: 2:30 p.m. ET ...

APGE | globenewswire | about 17 days ago | Neutral

Apogee Therapeutics to Participate in Upcoming March Investor ConferencesApogee Therapeutics SAN FRANCISCO and BOSTON, Feb. 25, 2025 (GLOBE NEWSWIRE) -- Apogee Therapeutics, Inc., (Nasdaq: APGE) today announced that members of management will participate at the following investor conferences. TD Cowen 45th Annual Health Care Conference Date: Tuesday, March 4, 2025 T...

APGE | finance.yahoo | about 17 days ago | Neutral

Profile

Apogee Therapeutics, Inc. Common Stock (APGE)

Apogee Therapeutics, Inc., through its subsidiary, operates as a biotechnology company that develops biologics for the treatment of atopic dermatitis (AD), asthma, chronic obstructive pulmonary disease (COPD), and related inflammatory and immunology indications. The company primarily develops APG777, a subcutaneous (SQ) extended half-life monoclonal antibody (mAb) for AD; and APG808, an SQ extended half-life mAb for COPD. Its earlier-stage programs comprise APG990, an SQ extended half-life mAb for the treatment of AD; and APG222, an extended half-life SQ antibodies for AD. Apogee Therapeutics, Inc. was incorporated in 2022 and is headquartered in Waltham, Massachusetts.

Exchange: NASDAQ

IPO Date: 7/14/2023

Sector: Healthcare

Industry: Biotechnology

Employees: 196

Address: 221 Crescent Street, Waltham, MA, United States, 02453

https://www.apogeetherapeutics.com

Quarterly Yearly

&ebsp;&ebsp;&ebsp;&ebsp;&ebsp;&ebsp;	12/31/2024	09/30/2024	06/30/2024	03/31/2024	12/31/2023	09/30/2023	06/30/2023	03/31/2023	12/31/2022	Totals
	12/31/2024	09/30/2024	06/30/2024	03/31/2024	12/31/2023	09/30/2023	06/30/2023	03/31/2023	12/31/2022	Totals
Assets	753.95K	776.29K	800.66K	823.66K	401.40K	426.42K	130.67K	142.02K	152.06K	4.41M
Current Assets	529.71K	534.48K	681.85K	820.61K	398.41K	426.42K	130.67K	142.02K	152.06K	3.82M
Cash And Short Term Investments	520.65K	526.05K	676.23K	816.20K	395.46K	422.85K	125.07K	141.33K	151.89K	3.78M
Net Receivables	4.70K	4.77K	-	-	-	-	-	-	-	9.47K
Other Current Assets	4.36K	3.66K	5.63K	4.41K	2.95K	1.41K	5.60K	529	57	28.61K
Non Current Assets	224.24K	241.80K	118.80K	3.05K	3.00K	199.999	3.47K	-	-	594.56K
Long Term Investments	210.42K	227.75K	113.39K	-	-	-	-	-	-	551.56K
Non Currrent Assets Other	498	514	468	107	101	199.999	-	-	-	1.89K
Liabilities	37.16K	41.88K	27.02K	22.18K	21.49K	17.18K	195.08K	11.19K	9.98K	383.17K
Current Liabilities	28.56K	32.61K	24.62K	21.55K	20.56K	17.18K	17.61K	11.19K	9.98K	183.86K
Accounts Payable	1.07K	2.22K	5.53K	4.30K	2.14K	1.21K	11.15K	965	418	29.00K
Other Current Liabilities	24.25K	27.53K	15.73K	16.11K	16.21K	14.76K	6.47K	10.23K	9.56K	140.85K
Non Current Liabilities	8.60K	9.27K	2.40K	630	932.999	-	177.47K	-	-	199.30K
Stockholder Equity	1.02M	734.40K	773.64K	801.48K	379.91K	501.28K	-71.19K	-52.31K	-39.78K	4.05M
Liabilities And Stockholders Equity	1.06M	776.29K	800.66K	823.66K	401.40K	518.46K	195.08K	11.19K	9.98K	4.60M
Totals		4.43M	3.94M	4.05M	4.16M	2.04M	2.35M	927.14K	418.36K	456.19K	22.77M

&ebsp;&ebsp;&ebsp;&ebsp;&ebsp;&ebsp;	12/31/2024	12/31/2023	12/31/2022	Totals
	12/31/2024	12/31/2023	12/31/2022	Totals
Assets	753.95K	401.40K	152.06K	1.31M
Current Assets	529.71K	398.41K	152.06K	1.08M
Cash And Short Term Investments	520.65K	395.46K	151.89K	1.07M
Other Current Assets	9.06K	2.95K	165	12.18K
Non Current Assets	224.24K	3.00K	-	227.23K
Long Term Investments	210.42K	-	-	210.42K
Non Currrent Assets Other	210.91K	401	-	211.31K
Liabilities	37.16K	21.49K	9.98K	68.63K
Current Liabilities	28.56K	20.56K	9.98K	59.10K
Accounts Payable	1.07K	2.14K	418	3.63K
Other Current Liabilities	24.25K	17.31K	9.56K	51.13K
Non Current Liabilities	8.60K	933	-	9.53K
Stockholder Equity	716.79K	379.91K	-39.78K	1.06M
Liabilities And Stockholders Equity	753.95K	401.40K	9.98K	1.17M
Totals		4.03M	2.05M	456.30K	6.53M

&ebsp;&ebsp;&ebsp;&ebsp;&ebsp;&ebsp;	Totals
	Totals
Totals		-

&ebsp;&ebsp;&ebsp;&ebsp;&ebsp;&ebsp;	Totals
	Totals
Totals		-

&ebsp;&ebsp;&ebsp;&ebsp;&ebsp;&ebsp;&ebsp;	12/31/2024	09/30/2024	06/30/2024	03/31/2024	12/31/2023	09/30/2023	06/30/2023	03/31/2023	09/30/2022	06/30/2022	Totals
	12/31/2024	09/30/2024	06/30/2024	03/31/2024	12/31/2023	09/30/2023	06/30/2023	03/31/2023	09/30/2022	06/30/2022	Totals
Cash From Operating Activities	-67.71K	-42.52K	-29.30K	-31.64K	-29.75K	-19.88K	-14.57K	-10.56K	-7.24K	-14.57K	-267.74K
Net Income	-67.22K	-49.02K	-33.82K	-32.09K	-31.73K	-20.84K	-18.89K	-12.53K	-19.66K	-1.82K	-287.60K
Depreciation	76	48	36	29	-	-	-	-	-	-	189
Extraordinary Items	-	-	-	-	-	-	-	-	-	-	-
Change To Liabilities	-	-	-	-	-	-	9.86K	-	-	221	10.08K
Change To Net Income	-	-	-	-	-	-	1.11K	1.11K	-	1.11K	3.34K
ChangeToOperatingActivities	-	-	-	-	-	-	-6.66K	-6.66K	-	1.59K	-11.72K
Capital Expenditures	-1	-751	-51	-351	-167	-	-	-	-	-	-1.32K
Cash From Financing Activities	44.36K	383	-150	450.52K	-213	317.30K	-1.69K	-1.69K	4.85K	-26	813.63K
Sale Purchase Of Stock	-	-	-	-	-0.213	-	-	-	-	-	-0.213
Other Cashflows From Financing Activities	828	383	391	24	-273.91K	1.69K	-1.694	-1.69K	-	-1.69K	-273.98K
Totals		-89.67K	-91.48K	-62.89K	386.49K	-335.78K	278.27K	-30.84K	-32.02K	-22.05K	-15.18K	-15.13K

&ebsp;&ebsp;&ebsp;&ebsp;&ebsp;&ebsp;&ebsp;	12/31/2024	12/31/2023	12/31/2022	Totals
	12/31/2024	12/31/2023	12/31/2022	Totals
Cash From Operating Activities	-171.17K	-74.76K	-16.43K	-262.36K
Net Income	-182.15K	-83.98K	-39.78K	-305.92K
Depreciation	189	-	-	189
Extraordinary Items	-	-	-	-
Capital Expenditures	-1.15K	-167	-	-1.32K
Cash From Financing Activities	495.11K	315.39K	183.618	810.68K
Other Cashflows From Financing Activities	1.63K	-273.91K	168.50K	-103.78K
Totals		142.45K	-117.43K	112.47K	137.49K

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