Latest news with #MichaelHenderson
Yahoo
19-05-2025
- Politics
- Yahoo
Louisiana Survey: Residents identify economy as most important problem
BATON ROUGE, La. (Louisiana First) — Results from the Louisiana Survey show how residents feel about the direction of the state, confidence in state government, economy and more. The top three problems respondents identified in the survey were economy, crime and education. Despite concerns about problems, data shows an upward trend in the public mood. Results from the online survey show an even split between those who believe the state is heading in the wrong direction and those who believe it is going in the right direction. In the telephone survey, 47% of respondents said the state is heading in the wrong direction, a drop from 68% in 2023. 'This year, we're seeing signs of optimism,' said Louisiana Survey Director Michael Henderson, Ph.D. 'A growing number of Louisianians now say the state is heading in the right direction. It's a modest shift, but a meaningful one, given how entrenched negative sentiment has been in recent years.' Attitude toward state government has also seen an increase in confidence from respondents, with the report showing a growth of 14 percentage points from 2022 to 2025. See which issues respondents named as the biggest in Louisiana. Issue Online Survey Telephone Survey Economy 27% 16% Crime 12% 15% Education 10% 15% State budget, taxes, and spending 8% 7% Infrastructure 6% 8% Health care 5% 3% Housing 4% 2% Coast, environment, and severe weather 3% 4% Insurance 2% 6% Immigration 2% <1% Other social issues (e.g., abortion, guns) 4% 5% Other issues 11% 15% Don't know/Refused 4% 5% Other survey findings: Nearly half of the respondents said crime has increased in the last year. Respondents said the state's criminal system isn't tough enough. The report shows 54% of online survey respondents and 39% of telephone survey respondents said it's not tough enough. Most respondents are in support of the death penalty for those with murder convictions. Results show the majority of respondents support marijuana legalization for personal use. Respondents said the state income tax and state sales tax are too high. Seventy percent who answered the online and telephone survey support more offshore drilling. Two-thirds of respondents who have homeowners insurance said premiums went up in the past year. A large majority of respondents support Louisiana raising salaries for public school teachers. Support dropped some when the question mentioned taxes to fund raises. Click here to see the full report. Louisiana is the 10th most dangerous US state, study shows Majority of Americans have concerns about Trump's Qatar jet plan: Poll Ascension Public Schools assistant superintendent to retire Johnson: 'Almost there' on Trump agenda bill, but more work to do Walmart responds to Trump comment that retailer should 'eat the tariffs' Louisiana Survey: Residents identify economy as most important problem Copyright 2025 Nexstar Media, Inc. All rights reserved. This material may not be published, broadcast, rewritten, or redistributed.
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
What's On
28-03-2025
- Entertainment
- What's On
Could there really be a massive resort moon landing in Dubai?
One small step for engineering, another potential giant leap for Dubai… Dubai is a city that has, since its very inception, treated engineering conventions with a sort of resting distrust face. If it wants to build a physics-defying, mega-tower, that seems to twist towards the teasing skies, requires a complete reinvention of elevator technology and just generally breaks all the rules of contemporary construction, it will (and has) go ahead and do exactly that. The word 'Impossible' was redacted from Dubai's dictionary a long time ago. CLICK THROUGH THE GALLERY FOR MORE ON MOON DUBAI What is the Dubai Moon? 3 of 12 One of the proposed locations, puts the moon in orbit of the world's tallest buildings, the Burj Khalifa The resort will feature a state of the art spa and wellness facility which (apologies in advance) will likely include out of this world relaxation ser One key feature will also be the resort's arena, big enough to host a crowd of 10,000 people for a variety of entertainment acts. Of course there'll be a 'night club' too. Not quite Zero Gravity, but close. It's set to include a conference centre, that will be a Sea Tranquility. There'll reportedly be a Jazz bar. Nice. Satellite system, another potential Moon Dubai location is at the base of Palm Jumeriah. Ever wanted to visit the moon? No? What if we guarantee this luna colony experience includes oxygen? We have no idea what sort of restaurants you'll find in a giant moon, but if cheese doesn't feature heavily, tables are getting flipped How do you get to a simulated lunar colony experience? In a lunar module/roller coaster of course. A giant Moon hotel also suggests the existence of giant moon suites. Creating a themed manmade archipelago in the Arabian Gulf, no problem – I'll take three please. An indoor ski slope, in a mall, in the desert – absolutely, but just make sure you squeeze in a black run. The world's tallest tower, most powerful solar farm, turning a vintage cruise ship into a hotel, record-breaking malls, artificial lake smithing, simulated reef building, giant observational wheel manufacturing… This is all pioneering, Sim City , fantastical fabrication fever dreaming, but one of the metropolis' most recently touted megaprojects goes perhaps even a small step beyond that. Into orbit A hotel cosplaying as the moon. That's the proposed USD 5 billion dollar, more than 300-metre-high venture from Moon World Resorts Inc. But how would it work? What lunacy would be contained within? Where will it be built? Do we really need a 1:100 scale hospitality Death Star? Are they actually even building it, or is it just a concept resort at this point? We have answers to all (eh, some) of these questions, and more, below. Lunar modules The design conceived by Canadian entrepreneur Michael Henderson, will comprise of a 4,000-room hotel, an arena capable of hosting 10,000 people, fine dining restaurants, a spa and a lunar colony experience. Basically pretending you went to the moon, which is exactly what some people (to be absolutely clear, not us) think Neil Armstrong and friends did. The proposed features also include reference to a nocturnal illumination show. Are they actually building it? No. At least, not yet. It's still very much in the exploration phase. But the minds behind the idea have kicked about a few options as to where the Luna base might find itself. The leading site, as depicted in the image that's been circulated, is the (appropriately enough) construction crater of the Dubai Pearl, at the base of Palm Jumeirah. Other mooted locations include a Burj Khalifa adjacent plot, although precisely where that might be remains unclear. More phases of the moon Moon World Resorts' Instagram channel suggests that the company is looking at builds in the USA, China, India, Spain and Brazil in addition to their UAE venture. Images: Moon World Resorts > Sign up for FREE to get exclusive updates that you are interested in
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
