Latest news with #APG279
Yahoo
12-05-2025
- Business
- Yahoo
Apogee Therapeutics Provides Business Update, Pipeline Progress and Reports First Quarter 2025 Financial Results
Phase 2 APEX trial of APG777 in atopic dermatitis advancing with interim Part A 16-week data expected in mid-2025 and Part B actively enrolling First patient dosed in Phase 1b trial of APG777 in mild-to-moderate asthma with readout expected in 1H 2026 APG279 on track to initiate Phase 1b head-to-head trial vs DUPIXENT in 2025 with readout expected in 2H 2026 Positive interim Phase 1b readout of APG808 in patients with mild-to-moderate asthma demonstrated rapid, robust and sustained suppression of FeNO, a biomarker of Type 2 inflammation that is associated with exacerbations in asthma $681.4 million cash, cash equivalents and marketable securities supports runway into Q1 2028 SAN FRANCISCO and WALTHAM, Mass., May 12, 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 business updates, pipeline progress and reported first quarter 2025 financial results. '2025 is poised to be a transformational year for Apogee, and we are pleased with the strong execution in the first quarter as we continue to advance therapies with the goal of reshaping the standard of care for patients living with I&I diseases,' said Michael Henderson, M.D., Chief Executive Officer of Apogee. 'We have made significant progress in our Phase 2 APEX trial of APG777, which is actively enrolling Part B and on track for the interim 16-week readout from Part A mid-year. Momentum continues across our programs, driven by the initiation of our Phase 1b trial of APG777 in patients with mild-to-moderate asthma, today's announcement of positive interim clinical trial results from our Phase 1b trial of APG808 in patients with mild-to-moderate asthma, as well as the positive Phase 1 interim readout for APG990, which exceeded all trial objectives and unlocked the potential for dosing APG279 (APG777 + APG990) two- to four- times per year with a single 2 mL co-formulated injection. Following these encouraging results from APG990, we are advancing our first-in-class combination strategy with plans to initiate a head-to-head Phase 1b study of APG279 versus DUPIXENT in AD later this year. With a very strong cash position and multiple catalysts across our portfolio in the months ahead, we are looking forward to an exciting and productive 2025 and 2026.' New independent market research reinforces APG777's potential to become a market leader in the rapidly expanding AD biologic space:Apogee conducted third-party quantitative market research in April 2025 and asked US patients and physicians the likelihood that they would switch to APG777 from their current or previous biologic assuming APG777 had similar efficacy and overall results to DUPIXENT and an every 3-month, or quarterly, injection maintenance schedule. Responses demonstrated that APG777 was highly preferred over current biologic options by patients and physicians 96% of patients currently on a biologic, both controlled and inadequately controlled, would likely switch to APG777. 80% of physicians would likely start their biologic naive patients on APG777, while 83% of physicians would likely switch inadequately controlled biologic patients to APG777. 67% of physicians are open to switching their controlled patients to a quarterly dose of APG777. Compared to a hypothetical daily oral with equivalent efficacy and safety, patients and providers prefer APG777's quarterly dosing profile: Patients prefer the APG777 profile by more than 3 to 1. Providers prefer the APG777 profile by nearly 4 to 1. 'Based on the recent market research we commissioned, APG777's potential quarterly dosing is highly preferred by both physicians and patients to other available options. Physicians expressed strong interest in both initiating new-to-biologic patients to APG777 as well as switching patients already on biologics to APG777, assuming comparable efficacy and safety to current biologics,' said Jeff Hartness, Chief Commercial Officer of Apogee. 'The AD biologic market is expanding rapidly—with year-to-date growth of 23% in total prescriptions and 44% in new-to-brand prescriptions—and new entrants are accelerating the shift from topicals to biologics. We believe APG777 is well positioned to transform the AD treatment landscape and significantly improve the quality of life for patients living with moderate-to-severe AD.' Pipeline Highlights and Upcoming Milestones Apogee continues to execute APG777 monotherapy program in AD and expansion indications: 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. The Phase 2 APEX clinical trial of APG777 is progressing, with Part A fully enrolled and Part B actively enrolling patients with moderate-to-severe AD. The company expects to report 16-week topline data from Part A of the trial in mid-2025 and from Part B in the second half of 2026. Apogee today announced that the first patient has been dosed in a Phase 1b trial of APG777 in patients with mild-to-moderate asthma. The primary endpoint of the trial is safety and tolerability, with secondary endpoints exploring pharmacokinetics (PK), FeNO suppression of APG777, with readout expected in the first half of 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 on track to initiate in 2025: APG990 is a novel, SQ, extended half-life mAb targeting OX40L, 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 co-formulating two extended half-life mAbs provides the potential for first-in-class and best-in-class dosing. In March 2025, Apogee reported positive APG990 Phase 1 interim results in healthy volunteers, unlocking potential maintenance dosing every three and six months for APG279 (APG777 + APG990) Apogee plans to initiate its first-in-class combination trial, a Phase 1b trial designed to evaluate the safety, PK, pharmacodynamics and efficacy of APG279 against DUPIXENT in patients with moderate-to-severe AD this year, with an interim readout expected in the second half of 2026. Progress continues in our 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. Positive interim data for APG808 Phase 1b trial in asthma reported: APG808 is a novel, SQ extended half-life mAb targeting IL-4Rα, a target with clinical validation across eight Type 2 allergic diseases. In preclinical studies, APG808 has similar binding and femtomolar affinity for IL-4Rα as compared to DUPIXENT and has demonstrated similar inhibition to DUPIXENT. Today, the company reported positive interim results of the Phase 1b trial of APG808 in patients with mild-to-moderate asthma. The results demonstrated that APG808 was well-tolerated, with multiple doses of APG808 resulting in rapid suppression of FeNO, a biomarker of Type 2 inflammation that is associated with exacerbations in asthma, with a maximal robust FeNO decrease from baseline of 53% and sustained FeNO decrease from baseline of 50% at 12 weeks. APG808's optimized PK profile coupled with FeNO suppression out to 12-weeks reinforce the potential for 2-months or longer maintenance dosing, offering a significant advantage compared to the current bi-weekly standard of care. First Quarter 2025 Financial Results Cash Position: Cash, cash equivalents and marketable securities were $681.4 million as of March 31, 2025, compared to $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. R&D Expenses: Research and development (R&D) expenses were $46.4 million for the quarter ended March 31, 2025, compared to $28.7 million for the quarter ended March 31, 2024. R&D expenses increased primarily due to the advancement of the pipeline and continued development of the company's programs, and increases in personnel-related expenses and equity-based compensation, associated with the growth in the company's R&D team. G&A Expenses: General and administrative (G&A) expenses were $16.7 million for the quarter ended March 31, 2025, compared to $9.5 million for the quarter ended March 31, 2024. G&A expenses increased primarily due to increases in personnel-related expenses and equity-based compensation, 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. Net Loss: Net loss was $55.3 million for the quarter ended March 31, 2025, compared to a net loss of $32.1 million for the quarter ended March 31, 2024. 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 ApogeeApogee 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 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) in AD, the Phase 2 trial of APG777 in EoE, and the Phase 1 trial of APG333 in healthy volunteers; the expected timing of and results from its clinical trials, including data from Part A and Part B of its Phase 2 trial of APG777 in AD, Phase 1b trial of APG279 in AD, Phase 1 trial of APG333 in healthy volunteers, Phase 1b trial of APG777 in asthma; its planned clinical trial designs; its plans for current and future clinical trials; the potential clinical benefit and half-life, PK profile and dosing regimen, and treatment outcomes of APG777, APG279, APG990, APG333, APG808, Apogee's other product candidates, including combination therapies, and any other potential programs; its planned business strategies; its expected timing for future pipeline updates; and its 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 Annual Report on 10-K for the year ended December 31, 2024, filed with the SEC on March 3, 2025, 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 THERAPEUTICS, CONSOLIDATED BALANCE SHEETS(UNAUDITED)(In thousands, except share data) MARCH 31,2025 DECEMBER 31,2024 Assets Current assets: Cash and cash equivalents $ 106,916 $ 141,789 Marketable securities 406,413 378,864 Prepaid expenses and other current assets 8,202 9,060 Total current assets 521,531 529,713 Long-term marketable securities 168,106 210,416 Property and equipment, net 5,679 1,959 Right-of-use asset, net 11,507 11,365 Other non-current assets 7,339 498 Total assets $ 714,162 $ 753,951 Liabilities and stockholders' equity Current liabilities: Accounts payable $ 2,445 $ 1,071 Lease liability 3,976 3,234 Accrued expenses and other current liabilities 26,539 24,255 Total current liabilities 32,960 28,560 Long-term liabilities: Lease liability, net of current 7,840 8,597 Total liabilities 40,800 37,157 Stockholders' equity: Common Stock; $0.00001 par value, 400,000,000 authorized, 59,526,170 issued and 58,304,801 outstanding as of March 31, 2025; 400,000,000 authorized, 59,478,725 issued and 58,062,898 outstanding as of December 31, 2024 1 1 Additional paid-in capital 1,033,542 1,021,794 Accumulated other comprehensive income 1,074 915 Accumulated deficit (361,255 ) (305,916 ) Total stockholders' equity 673,362 716,794 Total liabilities and stockholders' equity $ 714,162 $ 753,951 APOGEE THERAPEUTICS, CONSOLIDATED STATEMENTS OF OPERATIONS(UNAUDITED)(In thousands) THREE MONTHS ENDED MARCH 31, 2025 2024 Operating expenses: Research and development $ 46,387 $ 28,716 General and administrative 16,709 9,465 Total operating expenses 63,096 38,181 Loss from operations (63,096 ) (38,181 ) Other income, net: Interest income, net 7,840 6,087 Total other income, net 7,840 6,087 Net loss before taxes (55,256 ) (32,094 ) Provision for income taxes (83 ) — Net loss after taxes $ (55,339 ) $ (32,094 ) Investor Contact:Noel KurdiVP, Investor RelationsApogee Therapeutics, Media Contact:Dan Budwick1AB Mediadan@ in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
03-03-2025
- Business
- Yahoo
Apogee Therapeutics' Investigational Atopic Dermatitis Potential Shows Strong Tolerability, Extended Half-Life in Early Trial
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: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 © 2025 Benzinga does not provide investment advice. All rights reserved.
Yahoo
03-03-2025
- Business
- Yahoo
Apogee Therapeutics Provides Pipeline Progress and Reports Full Year 2024 Financial Results
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 ApogeeApogee 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 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 THERAPEUTICS, 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, 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 KurdiVP, Investor RelationsApogee Therapeutics, Media Contact:Dan Budwick1AB Mediadan@ in to access your portfolio
Associated Press
03-03-2025
- Business
- Associated Press
Apogee Therapeutics Provides Pipeline Progress and Reports Full Year 2024 Financial Results
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 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. Media Contact: Dan Budwick 1AB Media
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03-03-2025
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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 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 DetailsApogee 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 A replay of the webcast will be available following the call. About APG990APG990 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 Forward Looking StatementsCertain 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 KurdiVP, Investor Relations Apogee Therapeutics, Media Contact:Dan Budwick 1AB dan@ in to access your portfolio
