Apogee Therapeutics, Inc.

APGE Healthcare Q1 2025

Document 1

EX-99.1 2 tm2514695d1_ex99-1.htm EXHIBIT 99.1

 

Exhibit 99.1

 

 

 

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, CA and Waltham, MA, May 12, 2025 – 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

 

o96% of patients currently on a biologic, both controlled and inadequately controlled, would likely switch to APG777.

 

 

 

 

 

 

o80% of physicians would likely start their biologic naive patients on APG777, while 83% of physicians would likely switch inadequately controlled biologic patients to APG777.

 

o67% 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:

 

oPatients prefer the APG777 profile by more than 3 to 1.

 

oProviders 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.

 

oThe 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.

 

oApogee 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 1H 2026.

 

oThe 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.

 

oIn 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)

 

oApogee 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.

 

oA 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.

 

oToday, 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.

 

oAPG808’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 Apogee

 

Apogee Therapeutics is a clinical-stage biotechnology company advancing novel biologics with potential for differentiated efficacy and dosing in the largest I&I markets, including for the treatment of AD, asthma, EoE, COPD and other I&I indications. Apogee’s antibody programs are designed to overcome limitations of existing therapies by targeting well-established mechanisms of action and incorporating advanced antibody engineering to optimize half-life and other properties. APG777, the company’s most advanced program, is being initially developed for the treatment of AD, which is the largest and one of the least penetrated I&I markets. With four validated targets in its portfolio, Apogee is seeking to achieve best-in-class efficacy and dosing through monotherapies and combinations of its novel antibodies. Based on a broad pipeline and depth of expertise, the company believes it can deliver value and meaningful benefit to patients underserved by today’s standard of care. For more information, please visit https://apogeetherapeutics.com.

 

 

 

 

 

 

Forward Looking Statements

 

Certain statements in this press release may constitute “forward-looking statements” within the meaning of the federal securities laws, including, but not limited to, statements regarding: Apogee’s plans for its current and future product candidates and programs; the anticipated timing of the initiation of its clinical trials, including the Phase 1b trial of APG279 (the combination of APG777 and APG990) 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 law.

 

 

 

 

 

 

APOGEE THERAPEUTICS, INC.

 

CONDENSED 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, INC.

 

CONDENSED 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 Kurdi

VP, Investor Relations

Apogee Therapeutics, Inc.

[email protected]

 

Media Contact:

Dan Budwick

1AB Media

[email protected]

 

 

 

 

Document 2

EX-99.2 3 tm2514695d1_ex99-2.htm EXHIBIT 99.2

 

Exhibit 99.2

 

 

 

Apogee Therapeutics Announces Positive Interim Results from the Phase 1b Trial of APG808, its Novel Half-life Extended IL-4Rα Antibody, in Patients with Mild-to-Moderate Asthma

 

Multiple doses of APG808 resulted in rapid suppression of FeNO, a biomarker of Type 2 inflammation associated with exacerbations in asthma, with a robust maximal FeNO decrease from baseline of 53%

 

APG808 demonstrated the potential for durable disease control in asthma with sustained FeNO decrease from baseline of 50% at 12 weeks

 

APG808's optimized formulation and potential best-in-class pharmacokinetic (PK) profile, combined with robust and sustained FeNO suppression through 12 weeks, support the potential for transformative dosing every 2-months or longer, compared to the current biweekly standard of care

 

APG808 was well tolerated with a favorable safety profile consistent with the anti-IL-4Rα class

 

Phase 1b proof-of-concept data validates Apogee's approach to designing potentially best-in-class biologics and builds on Apogee's track record of execution

 

SAN FRANCISCO and BOSTON, May 12, 2025 -- 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 data from its Phase 1b trial of APG808, a novel half-life extended IL-4Rα antibody, in patients with mild-to-moderate asthma.

 

“Today’s results from the APG808 Phase 1b trial mark a significant milestone in its clinical development, as APG808 demonstrated a favorable safety profile and encouraging initial efficacy in patients with asthma,” said Michael Henderson, M.D., Chief Executive Officer of Apogee. “With its potential best-in-class PK profile, APG808 could substantially improve clinical outcomes for patients with asthma over the biweekly current standard of care and enable dosing as infrequently as every two months or longer. We believe today’s progress reinforces our ability to soundly execute and build a leading I&I company poised to redefine treatment paradigms for patients worldwide.”

 

The Phase 1b double-blind, placebo-controlled, multiple-dose trial evaluated the safety and tolerability of APG808 in 22 adult patients with mild-to-moderate asthma. The trial also evaluated fractional exhaled nitric oxide concentration (FeNO), TARC, and pSTAT6. Participants were randomized 3:1, receiving 600mg of APG808 or placebo on day 1 and day 29.

 

 

 

 

Key results include:

 

·Multiple dose regimen of APG808 was well tolerated in asthmatic patients through 12 weeks of available follow-up.

 

oThe most common treatment-emergent adverse events (TEAEs) observed were headache, injection site erythema, and upper respiratory tract infections.

 

oThere were no Grade 3 TEAEs or severe adverse events. No adverse events led to study discontinuation.

 

·Multiple doses of APG808 resulted 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 also demonstrated sustained and near-complete reduction in pSTAT6 as well as deep reduction of TARC maintained through 12 weeks, two key Type 2 inflammatory biomarkers.

 

·APG808's optimized formulation and potential best-in-class PK profile along with durable FeNO suppression out to 12-weeks support potential for 2-month or longer maintenance dosing.

 

About APG808

 

APG808 is a novel, subcutaneous extended half-life monoclonal targeting IL-4Rα, a target with clinical validation across eight Type 2 allergic diseases, for the potential treatment of asthma, COPD and other inflammatory and immunology indications. In preclinical studies, APG808 has similar binding and femtomolar affinity for IL-4Rα as compared to DUPIXENT and has demonstrated similar inhibition to DUPIXENT. Asthma is one of the most common non-communicable diseases and, for a substantial number of patients, has an impact on quality of life and is estimated to affect 40 million adults and 12 million children in the United States, France, Germany, Italy, Japan, Spain and the United Kingdom, with prevalence rates of 5% to 8% in many countries. APG808 Phase 1 results demonstrated a potential best-in-class PK profile supporting the potential for every two- to three- month maintenance dosing.

 

About Apogee

 

Apogee Therapeutics is a clinical-stage biotechnology company advancing novel biologics with potential for differentiated efficacy and dosing in the largest I&I markets, including for the treatment of AD, asthma, EoE, COPD and other I&I indications. Apogee’s antibody programs are designed to overcome limitations of existing therapies by targeting well-established mechanisms of action and incorporating advanced antibody engineering to optimize half-life and other properties. APG777, the company’s most advanced program, is being initially developed for the treatment of AD, which is the largest and one of the least penetrated I&I markets. With four validated targets in its portfolio, Apogee is seeking to achieve best-in-class efficacy and dosing through monotherapies and combinations of its novel antibodies. Based on a broad pipeline and depth of expertise, the company believes it can deliver value and meaningful benefit to patients underserved by today’s standard of care. For more information, please visit https://apogeetherapeutics.com.

 

 

 

 

Forward Looking Statements

 

Certain statements in this press release may constitute “forward-looking statements” within the meaning of the federal securities laws, including, but not limited to, statements regarding: Apogee’s planned clinical trial designs; the potential clinical benefit, PK profile and dosing regimen, and treatment outcomes of APG808; the potential for APG808 to improve clinical outcomes for patients with asthma over current standard of care, and Apogee's ability to execute on its planned business strategies. 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 law.

 

Investor Contact:

Noel Kurdi

VP, Investor Relations

Apogee Therapeutics, Inc.

[email protected]

 

Media Contact:

Dan Budwick

1AB

[email protected]

 

 

 

Document 3

EX-99.3 4 tm2514695d1_ex99-3.htm EXHIBIT 99.3

 

Exhibit 99.3

 

Title text 2 MAY 12, 2025 APG808 Phase 1b interim results

 

 

2 © Apogee Therapeutics, Inc APG808 PHASE 1b This presentation contains certain "forward - looking statements" within the meaning of applicable securities laws. Other than sta tements of historical facts, all statements included in this presentation are forward - looking statements, including statements about our plans for APG808; treatment outcomes of APG808; the potential for APG808 to improve clinical outcomes for patients with asthma over the current standard of care; the potential safety of APG808 and the potential clinical benefit of APG 808. In some cases, you can identify forward - looking statements by terms such as “anticipate,” “believe,” “can,” “could,” “design,” “estimate,” “expect,” “intend,” “likely,” “may,” “might,” “p lan,” “potential,” “predict,” “suggest,” “target,” “will,” “would,” or the negative of these terms, and similar expressions intended to identify forward - looking statements. The forward - looking statements are based on our beliefs, assumptions and expectations of future performance, taking into account the information currently available to us. These statements are only predictions base d u pon our current expectations and projections about future events. Forward - looking statements are subject to known and unknown risks, uncertainties and other factors that may cause our actual res ults, level of activity, performance or achievements to be materially different from those expressed or implied by such forward - looking statements, including those risks described in “Ris k Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in our Annual Report on Form 10 - K for the year ended December 31, 2024, filed wit h the U.S. Securities and Exchange Commission (“SEC”) on March 3, 2025, our Quarterly Report on Form 10 - Q for the three months ended March 31, 2025, to be filed with the SEC on May 12, 2025, and subsequent disclosure documents we may file with the SEC. Although we have attempted to identify important factors that could cause actual results to differ materially f rom those contained in forward - looking statements, there may be other factors that cause results not to be as anticipated, estimated or intended. This presentation concerns a drug candidate that is under clinical investigation, and which has not yet been approved by the U.S . Food and Drug Administration. It is currently limited by federal law to investigational use, and no representation is made as to its safety or effectiveness for the purposes for which it is bei ng investigated. The assumptions used in the preparation of this presentation, although considered reasonable by us at the time of preparation , m ay prove to be incorrect. You are cautioned that the information is based on assumptions as to many factors and that actual results may vary from the results projected, and such variations m ay be material. Accordingly, you should not place undue reliance on any forward - looking statements contained herein or rely on them as predictions of future events. All forward - looking statemen ts in this presentation apply only as of the date made and are expressly qualified by the cautionary statements included in this presentation. We do not undertake to update any forward - lookin g statements, except in accordance with applicable securities laws. The trademarks, trade names and service marks appearing in this presentation are the property of their respective owners. Cer tai n information contained in this presentation relate to or are based on studies, publications and other data obtained from third - party sources as well as our own internal estimates and resear ch. While we believe these third - party sources to be reliable as of the date of this presentation, it has not independently verified, and makes no representation as to the adequacy, fairness , a ccuracy or completeness of, any information obtained from third - party sources. Disclaimers and Forward - looking Statements

 

 

3 © Apogee Therapeutics, Inc APG808 Phase 1b interim data met or exceeded trial objectives APG808 PHASE 1b NOTE: 1 Mean change from baseline in FeNO (ppb) and mean percent change from baseline FeNO , maximum mean reduction at D36. FeNO = fractional exhaled nitric oxide. Ppb = parts per billion. Data reported through week 12. GOAL Show durable suppression of FeNO supporting every 2 - month dosing or less frequent Sustained >30 ppb reduction from baseline through week 12 RESULT ACHIEVED GOAL Confirm safety of APG808 as monotherapy in an asthma patient population Multiple doses of 600 mg were well - tolerated RESULT ACHIEVED GOAL Demonstrate activity of APG808 via maximal suppression of FeNO in line with standard of care (~10 - 15 ppb change from baseline) Maximum FeNO reduction of 32 ppb (53% decrease from baseline) 1 RESULT EXCEEDED

 

 

4 © Apogee Therapeutics, Inc Design elements Schematic Double - blind, placebo - controlled two - dose regimen in patients with asthma N = 22 1 Key inclusion criteria: • Mild - to - moderate asthma • FeNO ≥25 ppb Primary endpoint: safety Additional endpoints: change in fractional exhaled nitric oxide (FeNO), PD 3:1 APG808 600 mg D 1, D29 Placebo APG808 PHASE 1b APG808 Phase 1b in mild - to - moderate asthma patients is fully enrolled with interim data for all patients NOTE: 1 22 patients were included in the safety population (17 treatment, 5 placebo), 21 in the PD population (16 treatment, 5 placeb o), and 20 in FeNO analysis population (15 treatment, 5 placebo). 1 patient was excluded from both PD and FeNO analysis populations after misdosing (received placebo at D1 and active dose D29) but included in the treatment safety population. 1 patient was excluded from FeNO analysis population due to FeNO falling below 25ppb at the baseline D1 measurement.

 

 

5 © Apogee Therapeutics, Inc APG808 PHASE 1b Baseline characteristics are in line with expectations NOTE: 1 APG808 safety population includes 1 patient who was misdosed (received placebo at D1 and active dose D29). 2 Tobacco use is inclusive of cigarettes, cigars, and smokeless tobacco or nicotine products. Multiple Dose APG808 600 mg D1, D29 N=17 1 Placebo D1, D29 N=5 26.5 (6.7) 33.0 (12.6) Age in years, mean (SD) 35.3% 40.0% Female 70.6% 100.0% White 75.8 (13.7) 73.7 (14.5) Weight in kg, mean (SD) 41.2% 60.0% Patients on daily ICS ± LABA (%) 88.2% 0.0% 11.8% 40.0% 20.0% 40.0% Tobacco use 2 Never Current Former 52.6 (27.4) 47.6 (10.8) FeNO in ppb, mean (SD) Demographics were generally well - balanced across cohorts

 

 

6 © Apogee Therapeutics, Inc APG808 PHASE 1b Multiple doses of APG808 were well - tolerated in mild - to - moderate asthma patients NOTE: TEAE = Treatment - Emergent Adverse Event. 1 1 patient was misdosed (received placebo on D1 and active dose on D29) but remains included in the APG808 safety population. This patient developed eczema before D29 (see detail on next page). Multiple Dose APG808 600 mg D1, D29 N=17 Placebo D1, D29 N=5 n (%) 16 (94.1%) 1 5 (100.0%) ≥1 TEAE 0 0 ≥1 serious TEAE 0 0 ≥1 Grade 3 TEAE 5 (29.4%) 2 (40.0%) ≥1 drug - related TEAE 0 0 ≥1 drug - related serious TEAE 0 0 ≥1 drug - related Grade 3 TEAE 0 0 Discontinued study due to TEAE The safety profile is in line with expectations for therapies targeting IL - 4Rɑ

 

 

© Apogee Therapeutics, Inc 7 APG808 PHASE 1b Multiple Dose APG808 600 mg D1, D29 N=17 Placebo D1, D29 N=5 AE occurring in ≥5% of total population 1 n (%) 8 (47.1%) 2 (40.0%) Headache 3 (17.6%) 0 (0.0%) Injection site erythema 2 (11.8%) 1 (20.0%) Upper respiratory tract infection 1 (6.3%) 1 (16.7%) 2 Eczema 2 (11.8%) 0 (0.0%) Injection site bruising 1 (5.9%) 1 (20.0%) Injection site pain 2 (11.8%) 0 (0.0%) Nausea NOTE: 1 Inclusive of AEs detected in ≥5% of total population (≥2 patients). 2 1 patient was misdosed (received placebo at D1 and active dose D29) but remains included in the APG808 safety population. This patient developed a case of eczema before D29. Therefore, the eczema case is included in the placebo column of this safety table. For the eczema row N = 6 for placebo and N=16 for APG808 group. Multiple doses of APG808 were well - tolerated in mild - to - moderate asthma patients

 

 

8 © Apogee Therapeutics, Inc APG808 PHASE 1b APG808 rapidly and durably suppressed FeNO through week 12 Maximum FeNO change from baseline FeNO change from baseline APG808 600 mg D1, D29 (N=15) APG808 showed greater mean FeNO reduction relative to DUPIXENT Placebo D1, D29 (N=5) - 40 - 30 - 20 - 10 0 FeNO , mean change from baseline “ SEM ( ppb ) FeNO , mean change from baseline ( ppb ) -40 -30 -20 -10 0 10 0 4 8 12 weeks NOTE: 2 patients were excluded from FeNO analysis population. 1 patient was misdosed (received placebo at D1 and active dose D29). 1 patient had FeNO below 25ppb at the baseline D1 measurement. Data are derived from different clinical trials conducted at different times, with differences in trial design and patient po pul ations. As a result, cross - trial comparisons cannot be made, and no head - to - head clinical trials have been conducted. DUPIXENT data is from the 300mg Q2W dose in two Ph3 studies. APG808 is an investigational drug and has not been approved by the FDA as safe and effective. BL = baseline. SOURCE: 1 Castro M, et al. NEJM 2018. 2 Rabe KF et al. NEJM, 2018. DUPIXENT 2 VENTURE DUPIXENT 1 QUEST APG808 Ph1b 36 34 53 BL FeNO (ppb)

 

 

9 © Apogee Therapeutics, Inc APG808 PHASE 1b APG808 rapidly and durably suppressed FeNO through week 12 Maximum percent FeNO change from baseline FeNO percent change from baseline APG808 600 mg D1, D29 (N=15) Placebo D1, D29 (N=5) - 60 0 - 40 - 20 NOTE: 2 patients were excluded from FeNO analysis population. 1 patient was misdosed (received placebo at D1 and active dose D29). 1 patient had FeNO below 25ppb at the baseline D1 measurement. Data are derived from different clinical trials conducted at different times, with differences in trial design and patient po pul ations. As a result, cross - trial comparisons cannot be made, and no head - to - head clinical trials have been conducted. DUPIXENT data is from the 300mg Q2W dose. APG808 is an investigational drug and has not been approved by the FDA as safe and effective. BL = baseline. SOURCE: 1 Castro M, et al. NEJM 2018. DUPIXENT 1 QUEST APG808 Ph1b 34 53 BL FeNO (ppb) FeNO , mean percent change from baseline “ SEM (%) -80 -60 -40 -20 0 20 0 4 8 12 FeNO , mean percent change from baseline ( % ) weeks APG808 showed greater percent FeNO reduction relative to DUPIXENT

 

 

10 © Apogee Therapeutics, Inc APG808 PHASE 1b APG808 rapidly and durably suppressed pSTAT6 and showed changes in TARC similar to DUPIXENT Median % pSTAT6 APG808 TARC suppression was similar to DUPIXENT APG808 shows near - complete pSTAT6 inhibition for ~3 months APG808 600 mg D1, D29 (N=16) Placebo D1, D29 (N=5) Median % pSTAT6 Median % change from baseline in TARC 0 50 100 0 4 8 12 weeks - 40 - 30 - 20 - 10 0 APG808 DUPIXENT 1 - 31 % - 34 % Median % change from baseline in TARC at 12 weeks 295pg/mL 245pg/mL Median baseline TARC NOTE: 1 patient was excluded from PD analysis population due to misdosing (received placebo at D1 and active dose D29). TARC data from different clinical trials conducted at different points in time, with differences in trial design, dosing regimen and patient populations. DUPIXENT data is from a Phase 3 study of moderate - to - severe asthma patients receiving DUPIXENT 300mg Q2W. Cross - trial comparisons cannot be made, and no head - to - head clinical trials have been conducted. APG808 is an investigational drug and has not been approved by the FDA as safe and effective. SOURCE: 1 Castro M, et al. NEJM 2018. pSTAT6 measured using flow cytometry of whole blood samples stimulated with 10 ng/mL IL - 13 (approximately 100 times the level of IL - 13 present in the sputum of severe asthma patients). APG808 data at 12 weeks, the longest available follow up. Similar results were obtained for pSTAT6 measured fo llowing stimulation with IL - 4.

 

 

Apogee /ˈ apəjē / noun The highest point in the development of something; a climax or culmination