UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
CURRENT REPORT
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| Item 2.02 | Results of Operations and Financial Condition. |
On August 12, 2024, Apogee Therapeutics, Inc. (the “Company”) issued a press release announcing its financial results for the quarter ended June 30, 2024.
A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated by reference herein. The exhibit furnished under Item 2.02 of this Current Report on Form 8-K shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Exchange Act or the Securities Act of 1933, as amended, regardless of any general incorporation language in such filing.
| Item 8.01 | Other Events. |
On August 12, 2024, the Company made available an updated corporate presentation on the Company’s website. A copy of the corporate presentation is filed herewith as Exhibit 99.2 and incorporated herein by reference.
| Item 9.01 | Financial Statements and Exhibits. |
(d) Exhibits. The following exhibits are being furnished or filed herewith:
EXHIBIT INDEX
| Exhibit No. |
Description | |
| 99.1 | Earnings Press Release, dated August 12, 2024 | |
| 99.2 | Corporate Presentation (August 2024) | |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document). | |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| Apogee Therapeutics, Inc. | ||
| Date: August 12, 2024 | By: | /s/ Michael Henderson, M.D. |
| Name: | Michael Henderson, M.D. | |
| Title: | Chief Executive Officer | |
Exhibit 99.1
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Apogee Therapeutics Provides Pipeline Progress and Reports Second Quarter 2024 Financial Results
Continued advancement of pipeline and execution towards expected milestones, including APG777 16-week proof-of-concept data from the Phase 2 Part A trial in 2H 2025, APG808 interim Phase 1 data in 4Q 2024, and APG990 Phase 1 trial initiation in healthy volunteers accelerated to 3Q 2024
APG333, a novel subcutaneous half-life extended anti-TSLP antibody, added to portfolio to provide for potential best-in-class combination efficacy across multiple respiratory indications, expected to enter the clinic in 2025
Apogee plans combination studies of 777 + 990 (IL-13 and OX40L) and 777 + 333 (IL-13 and TSLP), with the potential for greater efficacy across I&I diseases, starting with the first clinical trial of the APG777 and APG990 combination in 2025
$790 million cash, cash equivalents and marketable securities with runway into 2028
SAN FRANCISCO, CA and WALTHAM, MA, August 12, 2024 – 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, chronic obstructive pulmonary disease (COPD) and other I&I indications, today reported pipeline highlights and second quarter financial results.
“The first half of this year has been marked with significant pipeline progress and a focus on further defining our strategy that will enable us to deliver on our goal of reshaping the standard of care for patients in I&I by developing treatments with potential best-in-class monotherapy and combination efficacy and improved dosing schedules,” said Michael Henderson, M.D., Chief Executive Officer of Apogee. “A key component of that strategy is combining several of our pipeline programs, including APG333, which is our newly added compound targeting TSLP. TSLP is a validated target with one compound approved for asthma without a biomarker requirement, and which has recent clinical data demonstrating potential for treatment of a broader respiratory disease population, including COPD. We have strategically built a unique portfolio of IL-13, IL-4Rα, OX40L and TLSP inhibitors that enable multiple combinations in dermatology and respiratory diseases with the potential for deeper and broader responses. With our continued execution of the pipeline, our expected milestones are on track and we have a strong cash position taking us into 2028. We look forward to discussing our programs and additional plans for combination approaches in further detail at our R&D Day in December this year.”
Pipeline and Corporate Highlights and Upcoming Milestones
| o | First patient dosed in APG777 Phase 2 trial and on track for Part A data in 2H 2025: 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. |
| o | In May, the company commenced dosing in the Phase 2 clinical trial of APG777 in patients with moderate-to-severe AD; 16-week proof-of-concept induction data from Part A of the trial are expected in the second half of 2025. |
| o | The trial is designed to combine the typical Phase 2a and 2b portions of a clinical trial into a single protocol. The primary endpoint of each part of the study is mean percentage change in EASI score from baseline to Week 16. |
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| o | The Phase 2 APG777 trial in asthma is expected to include APG777 as a monotherapy and APG777 in combination with APG333, combining IL-13 and TSLP inhibition, pending Phase 1 clinical trial data from APG333. |
| o | APG333, a novel SQ half-life extended anti-TSLP antibody, added to portfolio earlier in the year, with supporting third-party evidence of broad potential of target inhibition in asthma and COPD: APG333 is a fully-human mAb targeting thymic stromal lymphopoietin (TSLP). TSLP is an epithelial cell-derived cytokine that has emerged as an attractive validated target for the treatment of I&I indications, with the potential to be used in combination with other mAbs for potentially greater efficacy in broader populations. TSLP plays important roles in Type 2 and Type 3 inflammation, particularly in both eosinophilic and non-eosinophilic inflammation. TSLP inhibition has been clinically validated, with one approved product on the market for the treatment of severe asthma without biomarker or phenotype restrictions. Based on its mechanism, TSLP inhibition could offer treatment to the approximately 40% of severe asthma patients with low Type 2 inflammation. |
| o | The company plans to nominate a development candidate by the end of 2024 and initiate a Phase 1 APG333 clinical trial in healthy volunteers (HV) in 2025. |
| o | Pending Phase 1 data, the company has the opportunity to combine APG333 with APG777, combining IL-13 and TSLP inhibition, to drive potential best-in-class efficacy in respiratory indications. |
| o | Phase 1 APG808 trial on track for 4Q 2024 interim data readout: APG808 is a 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 (pSTAT6 induction, inhibition of TF-1 proliferation, and inhibition of TARC secretion). |
| o | The company expects to share interim data from the Phase 1 HV clinical trial in the fourth quarter of 2024. |
| o | Pending results of the Phase 1 HV clinical trial, Apogee plans to initiate a Phase 1b clinical trial in asthma with data expected in the first half of 2025. |
| o | Phase 1 APG990 HV clinical trial set to start ahead of schedule in 3Q 2024: APG990 is a novel, SQ half-life extended mAb targeting OX40L, initially being developed for AD. OX40L is located further upstream in the inflammatory pathway than IL-13 or IL-4Rα and targeting it could have broader impact on the inflammatory cascade by inhibiting Type 1, Type 2 and Type 3 pathways. With current approved biologics only targeting two mechanisms of action (IL-13 and IL4Rα) in AD, OX40L could represent another therapeutic option for patients, especially the portion of patients who do not benefit from currently available treatments. In addition, based on our preclinical studies, we believe APG990 can be dosed every three to 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. |
| o | The company has received regulatory clearance in Australia and plans to initiate a Phase 1 APG990 clinical trial in HVs in the third quarter of 2024 with interim data expected in 2025. |
| o | Potential to expand patient reach with best-in-class efficacy and dosing with planned APG777 and APG990 combination approach, combining IL-13 and OX40L inhibition: Apogee plans to develop APG777 and APG990 together as a potential first-in-class coformulation 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. These combined mechanisms offer the potential for improved clinical responses over monotherapy across a variety of I&I diseases while our approach of coformulating two extended half-life mAbs holds the potential for best-in-class dosing. |
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| o | The company plans to initiate the first clinical trial of the APG777 and APG990 combination in 2025. |
| o | Expanded board of directors: In May, drug development expert Lisa Bollinger, M.D., joined Apogee’s board of directors. Dr. Bollinger has over 30 years of experience in drug development, with deep regulatory experience gained within both the U.S. FDA and multinational biotechnology and pharmaceutical companies, and most recently served as Vice President, Regulatory Affairs, Global Regulatory Affairs and Clinical Safety at Merck, where she led the general medicine therapeutic area in regulatory affairs. |
| o | Apogee Therapeutics 2024 Virtual R&D Day to be held in December: The company plans to highlight progress across its pipeline and showcase its path to reshaping the standard of care in I&I by bringing forward monotherapy and combination treatments that offer the potential for best-in-class efficacy and improved dosing. |
Second Quarter Financial Results
| o | Cash Position: As of June 30, 2024, Apogee had cash, cash equivalents and marketable securities of $789.6 million. Apogee expects that its existing cash will enable it to fund its current operating expenses into the first quarter of 2028. |
| o | Research & Development (R&D) Expenses: R&D expenses for the second quarter of 2024 were $33.2 million, compared to $13.9 million for the second quarter of 2023. R&D expenses increased primarily due to further development of the company’s APG777, APG808 and APG990 and APG333 programs and advancement of its pipeline into clinical trials, preclinical testing of potential combinations, as well as increases in personnel costs, including equity-based compensation expense, associated with the growth of its R&D team. |
| o | General and Administrative (G&A) Expenses: G&A expenses for the second quarter of 2024 were $10.9 million, compared to $4.9 million for the second quarter of 2023. G&A expenses increased primarily due to increases in personnel costs, including equity-based compensation, associated with the growth of the company’s G&A team, as well as increased costs related to being a public company, including for legal, IT and professional services, and to support the growth of the business. |
| o | Net Loss: Net loss for the second quarter of 2024 was $33.8 million, compared to the net loss for the second quarter of 2023 which was $18.9 million. 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 inflammatory and immunology (I&I) markets, including for the treatment of atopic dermatitis (AD), asthma, chronic obstructive pulmonary disease (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 www.apogeetherapeutics.com.
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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, its plans for current and future clinical trials, including a Phase 2 trial for APG777 in asthma, a Phase 1b trial of APG808 in asthma, a Phase 1 trial for APG990, and a Phase 1 trial for APG333; Apogee’s plans for clinical trial design; the anticipated timing of the initiation of and results from Apogee’s clinical trials, including data from Apogee’s Phase 2 trial of APG777 and Apogee’s Phase 1 trial of APG808; the potential clinical benefit and half-life of APG777, APG808, APG990, APG333 and any other potential programs, including combination therapies; Apogee’s expected timing for future pipeline updates; and expectations regarding the time period over which Apogee’s capital resources will be sufficient to fund Apogee’s 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 Form 10-K for the year ended December 31, 2023, filed with the SEC on March 5, 2024, Quarterly Report on 10-Q for the quarterly period ended March 31, 2024, filed with the SEC on May 13, 2024, and subsequent disclosure documents we 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.
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APOGEE THERAPEUTICS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(UNAUDITED)
(In thousands, except unit/share data)
| JUNE 30, 2024 | DECEMBER 31, 2023 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 307,299 | $ | 118,316 | ||||
| Marketable securities | 368,929 | 277,143 | ||||||
| Prepaid expenses and other current assets | 5,625 | 2,950 | ||||||
| Total current assets | 681,853 | 398,409 | ||||||
| Long-term marketable securities | 113,395 | — | ||||||
| Property and equipment, net | 714 | 377 | ||||||
| Right-of-use asset, net | 4,227 | 2,217 | ||||||
| Other non-current assets | 468 | 401 | ||||||
| Total assets | $ | 800,657 | $ | 401,404 | ||||
| Liabilities and stockholders' equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 5,527 | $ | 2,143 | ||||
| Lease liability | 1,682 | 1,101 | ||||||
| Accrued expenses | 17,408 | 17,314 | ||||||
| Total current liabilities | 24,617 | 20,558 | ||||||
| Long-term liabilities: | ||||||||
| Lease liability, net of current | 2,401 | 933 | ||||||
| Total liabilities | 27,018 | 21,491 | ||||||
| Commitments and contingencies (Note 9) | ||||||||
| Stockholders' equity: | ||||||||
| Common Stock; $0.00001 par value, 400,000,000 authorized, 58,481,214 issued and 56,676,465 outstanding as of June 30, 2024; 400,000,000 authorized, 50,655,671 issued and 48,338,769 outstanding as of December 31, 2023 | 1 | — | ||||||
| Additional paid-in capital | 963,607 | 503,354 | ||||||
| Accumulated other comprehensive (loss) income | (289 | ) | 329 | |||||
| Accumulated deficit | (189,680 | ) | (123,770 | ) | ||||
| Total stockholders’ equity | 773,639 | 379,913 | ||||||
| Total liabilities and stockholders’ equity | $ | 800,657 | $ | 401,404 | ||||
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APOGEE THERAPEUTICS, INC.
CONDENSED
CONSOLIDATED STATEMENT OF OPERATIONS
(UNAUDITED)
| THREE MONTHS
ENDED JUNE 30, | SIX MONTHS
ENDED JUNE 30, | |||||||||||||||
| 2024 | 2023 | 2024 | 2023 | |||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | $ | 33,206 | $ | 13,946 | $ | 61,922 | $ | 22,401 | ||||||||
| General and administrative | 10,916 | 4,939 | 20,381 | 9,142 | ||||||||||||
| Total operating expenses | 44,122 | 18,885 | 82,303 | 31,543 | ||||||||||||
| Loss from operations | (44,122 | ) | (18,885 | ) | (82,303 | ) | (31,543 | ) | ||||||||
| Other income, net: | ||||||||||||||||
| Interest income, net | 10,306 | — | 16,393 | 133 | ||||||||||||
| Total other income, net | 10,306 | — | 16,393 | 133 | ||||||||||||
| Net loss | $ | (33,816 | ) | $ | (18,885 | ) | $ | (65,910 | ) | $ | (31,410 | ) | ||||
Investor Contact:
Noel Kurdi
VP, Investor Relations
Apogee Therapeutics, Inc.
Noel.Kurdi@apogeetherapeutics.com
Media Contact:
Dan Budwick
1AB Media
dan@1abmedia.com
Exhibit 99.2
CORPORATE OVERVIEW August 2024
2 © Apogee Therapeutics, Inc. Disclaimers and Forward - looking statements This presentation contains certain "forward - looking statements" within the meaning of applicable securities laws . Other than statements of historical facts, all statements included in this presentation are forward - looking statements, including statements about our plan s our plans for our current and future product candidates and programs, our plans for current and future clinical trials, including a Phase 2 trial for APG 777 in asthma, a Phase 1 b trial of APG 808 in asthma, a Phase 1 trial for APG 990 , and a Phase 1 trial for APG 333 ; our plans for clinical trial design ; the anticipated timing of the initiation of and results from our clinical trials, including data from our Phase 2 trial of APG 777 and our Phase 1 trial of APG 808 ; the potential clinical benefit and half - life of APG 777 , APG 808 , APG 990 , APG 333 and any other potential programs, including combination therapies ; our expected timing for future pipe line updates ; our expectations regarding the time period over which our capital resources will be sufficient to fund our anticipated operations, and estimates of market size . In some cases, you can identify forward - looking statements by terms such as “anticipate,” “believe,” “can,” “could,” “design,” “estimate,” “expect,” “intend,” “likely,” “may,” “might,” “plan,” “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 based upon 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 results, 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 “Risk 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 , 2023 , filed with the SEC on March 5 , 2024 , our Quarterly Report o n Form 10 - Q for the quarter ended March 31 , 2024 , filed with the SEC on May 13 , 2024 , and subsequent disclosure documents we may file with the U . S . Securities and Exchan ge Commission . Although we have attempted to identify important factors that could cause actual results to differ materially from 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 drug candidates that are under clinical investigation, and which have not yet been approved by the U . S . Food and Drug Administration . These are currently limited by federal law to investigational use, and no representation is made as to their safety or effectiveness for the purposes for which they are being investigated . The assumptions used in the preparation of this presentation, although considered reasonable by us at the time of preparation, may 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 may 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 statements 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 - looking 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 . Certain 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 research . 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, accuracy or completeness of, any information obtained from third - party sources .
3 © Apogee Therapeutics, Inc. Apogee plans to reshape the current standard of care for I&I diseases with its potential therapies Best - in - class monotherapy in atopic dermatitis • Less frequent dosing with potential for increased efficacy through higher exposures Best - in - class combination therapies in asthma and COPD • Strategic optionality to combine orthogonal validated mechanisms across pipeline First - in - class combination therapy in atopic dermatitis • Rational combination targeting orthogonal mechanisms with potential for best - in - class efficacy and dosing Broad potential in I&I with 10+ possible expansion indications
4 © Apogee Therapeutics, Inc. Apogee’s approach is to achieve differentiated efficacy and dosing in the markets it is pursuing Strategy Program Discovery Preclinical Phase 1 Phase 2 Phase 3 Potential best - in - class monotherapy in AD APG777 IL - 13 APG808 IL - 4R α APG990 OX40L APG333 TSLP APG777 ± APG990 IL - 13 ± OX40L APG777 ± APG333 IL - 13 ± TSLP Additional combination(s) IL - 13/ IL - 4R α + OX40L/ TSLP The Apogee agents mentioned above are currently under investigation. Their safety and effectiveness for the listed target ind ica tions have not yet been established. (1) Pending final data from our Phase 1 trials of APG777 and APG333 in healthy participants, we may initiate a Phase 2 trial in asthma and expect to further evaluate opportuni tie s to develop APG777 and the APG777+APG333 combination for other I&I indications, including alopecia areata, chronic rhinosinusitis with nasal polyps, chronic spontaneous urticaria, eosinophilic es ophagitis and prurigo nodularis. Higher exposures for better efficacy with less frequent dosing Atopic Dermatitis 2H 2025: Phase 2 16 - week induction PoC data Potential first - or best - in - class combination approaches Rational combinations to drive broader + deeper responses Healthy Volunteers Q4 2024: Initial Phase 1 PK and safety in HVs 2024: DC nomination 2025: Initiate Phase 1 PK & safety in HVs Atopic Dermatitis 2025: Clinical trial initiation COPD Q4 2024: Additional combination(s) to be announced at R&D Day Asthma TBD: Clinical trial initiation 1 Healthy Volunteers 2025 : Initial Phase 1 PK & safety in HVs Potential best - in - class mAbs for combinations Strategic optionality to combine orthogonal mechanisms across pipeline
5 © Apogee Therapeutics, Inc. Apogee mAbs are engineered for best - in - class properties, including half - life extension Potential for PK that: • Optimizes exposures • Decreases variability • Increases half - life • Designed to maximize antibody recycling • Drug exists at higher levels for longer effect Potency Viscosity PK Stability Backbone Based on clinically - validated epitopes with performance across five properties:
6 © Apogee Therapeutics, Inc. • AD, asthma and COPD are the largest and least penetrated markets • Mature I&I markets have consistently achieved high biologics penetration (~30 - 70% after 15 - 20 years), suggesting potential for significant growth in AD (8%), asthma (~20%) and COPD (0%) Apogee is pursuing the largest I&I markets with a de - risked development approach; AD is the largest Estimated population size (in millions) Moderate or severe, WW 59.6M COPD NOTE: IBD = Inflammatory bowel disease; RA = Rheumatoid arthritis; PsO = Psoriasis; COPD = Chronic obstructive pulmonary dise ase ; AD = Atopic dermatitis SOURCE: Academic journals, disease foundations, WHO, CDC, census data , analyst research US biologics penetration: PsO 26.9M RA 13.5M IBD 2.6M Asthma 65.5M 25.1M AD 81.6M 60% 0% Apogee’s current indications
Potential best - in - class monotherapy in atopic dermatitis
8 © Apogee Therapeutics, Inc. 0 2 4 6 8 10 12 14 16 18 20 22 24 50 40 60 0 70 100 80 90 Dosing Interval (weeks) Efficacy (PASI - 75, %) In psoriasis, an analog to AD, Skyrizi has taken the lead with quarterly dosing NOTE: Year denotes US launch year for adults with moderate to severe plaque psoriasis. Efficacy data are derived from differe nt clinical trials at different points in time, with differences in trial design, patient populations, and statistical analysis. As a result, cross - trial comparisons cannot be made. No head - to - head trials have been conducted among all biologics shown. Assumes 1 EUR = 1.07 USD. 1 Real - world evidence shows Skyrizi patients experienced fewer drug changes and a higher probability of drug survival compared wit h those treated with other biologic therapies for PsO and PsA SOURCE: Armstrong AW, et al JAMA Dermatol. 2020, Gordon KB, et al Lancet 2021. Reich K, et al Lancet 2021 . GlobalData. EvaluatePharma . USPIs. Wall Street research and management projections. Erik L et al ACR Convergence 2023. PsO = Psoriasis. PsA = Psoriatic Arthritis. Most pts respond (83 - 89% PASI - 75) $10.0B (Approved 2019) $4.9B (Approved 2009) $5.2B (Approved 2017) $5.3B (Approved 2015) $2.5B (Approved 2016) $4.0B (Approved 2008) Biologics with estimated WW peak sales in psoriasis and approval year $4.3B (Approved 2023) APG777 $1.9B (Approved 2004) • In 2024, 6 biologics each projected to exceed $2B in PsO alone • With quarterly dosing, Skyrizi leads a crowded market with 35% share • Patients stay on Skyrizi longer and are less likely to switch 1
9 © Apogee Therapeutics, Inc. There is significant whitespace in the landscape of approved and in - development biologics for AD NOTE: Only DUPIXENT and ADBRY are approved in th e US . SOURCE: 1. Lebrikizumab 250mg Q2W Ph3 avg. Silverberg JI et al. AAD 2022 2. Dupilumab 300 mg Q2W mono Ph3 avg. DUPIXENT USP I 3 . Tralokinumab 300 mg Q2W mono Ph3 avg. Adbry USPI 4. CBP - 201 300 mg Q2W Ph2. Connect Biopharma Press Release Jan. 5, 2022 5. Nemolizumab 30 mg Q4W Ph3 avg. Silverberg J et al EADV 2023 6. Rocatinlimab 150mg Q4W Ph2b Guttman - Yassky E et al Lancet 2023 7. Amlitelimab 250mg Q4W Ph2b Weidinger S et al EADV oral presentation 2023. Efficacy data are derived from different clinical trials at different points in time, with differences in trial design and patient populations. As a result, cross - trial comparisons cannot be made, and no head - to - head clinical trials have been conducted. APG777 0 2 4 6 8 10 12 14 16 18 20 22 24 55 60 50 65 45 70 40 75 35 80 30 85 0 90 100 95 Nemolizumab Dosing Interval (weeks) CBP - 201 Amlitelimab Tralokinumab Dupilumab Lebrikizumab Rocatinlimab Efficacy (EASI - 75, %)
10 © Apogee Therapeutics, Inc. 0 2 4 6 8 10 12 14 16 18 20 22 24 65 55 70 50 75 45 80 60 85 40 90 35 95 30 100 0 Amlitelimab Rocatinlimab Dupilumab Nemolizumab CBP - 201 Tralokinumab Lebrikizumab Dosing Interval (weeks) Apogee is pursuing potentially best - in - class monotherapy and first - in - class combination in AD NOTE: *Positioning of Apogee programs is illustrative and based on interim Phase 1 results for APG777 only and illustrates wh at we believe we can potentially achieve. Only DUPIXENT and ADBRY are approved. SOURCE: 1. Lebrikizumab 250mg Q2W Ph3 avg. Silverberg JI et al. AAD 2022 2. Dupilumab 300 mg Q2W mono Ph3 avg. DUPIXENT USPI 3. Tralokinumab 300 mg Q2W mono Ph3 avg. Adbry USPI 4. CBP - 201 300 mg Q2W Ph2. Connect Biopharma Press Release Jan. 5, 2022 5. Nemolizumab 30 mg Q4W Ph3 avg. Silverberg J et al EADV 2023 6. Rocatinlimab 150mg Q4W Ph2b Guttman - Yassky E et al Lancet 2023 7. Amlitelimab 250mg Q4W Ph2b Weidinger S et al EADV oral presentation 2023. Efficacy data are derived from different clinical trials at different points in time, wi th differences in trial design and patient populations. As a result, cross - trial comparisons cannot be made, and no head - to - head clinical trials have been conducted. Efficacy (EASI - 75, %) Testing ~30 - 40% higher exposures than lebrikizumab in induction Potential for every 3 - or 6 - month maintenance dosing APG777* Potential first - in - class IL - 13 + OX40L combination APG777 + APG990* Potential for best - in - class efficacy APG777
11 © Apogee Therapeutics, Inc. APG777 leverages lebrikizumab's mechanism to deliver a potentially best - in - class, pipeline - in - a - product antibody 0.6 1.4 0.5 0.6 STAT6 TARC 13.4 IC 90 (nM) APG777 Lebri DUPIXENT Overlapping region Human IL - 13 APG777's epitope on IL - 13 overlaps with lebrikizumab’s and leverages proven MoA and biology APG777 is as potent as lebrikizumab and DUPIXENT in key preclinical assays NOTE: MoA = Mechanism of Action. APG777 disrupts Type 2 inflammation by preventing formation of IL - 13R α1 / IL - 4R α heterodimer 1.4 APG777
APG777 Clinical Data
13 © Apogee Therapeutics, Inc. APG777 exhibited a potentially best - in - class PK profile with a half - life of ~75 days • Slow clearance, resulting in half - life of ~75 days • Dose - proportional increases in both Cmax and AUC PK demonstrated dose - proportionality and half - life of ~75 days (approximately 3x lebrikizumab ) • Initial multiple - dose data consistent with PK profile from SAD cohorts Multi - dose concentration - time profile Single - dose concentration - time profile APG777 Phase 1 Dose 1 Dose 2
14 © Apogee Therapeutics, Inc. pSTAT6 and TARC are biomarkers of IL - 13 target engagement and AD severity 1. pSTAT6 is a proximal and sensitive marker of IL - 13 receptor activation APG777 Phase 1 biomarkers Taken together, APG777’s reduction of these biomarkers confirms inhibition of IL - 13 signaling and allows comparison to other agents 2. TARC is historically correlated with AD severity and initial treatment response APG777 Phase 1
15 © Apogee Therapeutics, Inc. Single dose APG777 showed near complete pSTAT6 inhibition for ~3 months (limit of available follow - up) 0 1 2 3 4 5 6 7 8 9 10 11 12 50 100 0 % pSTAT6 Weeks Placebo (N=4) 300 mg (N=1) 600 mg (N=6) 1200 mg (N=6) Sustained APG777 pSTAT6 inhibition supports ability to suppress IL - 13 signaling at potential maintenance doses of Q3M+ Median percent pSTAT6 NOTE: N = 1 in cohort 1 due to the accelerated timing of study enrollment relative to assay validation. No data has been publ ish ed showing DUPIXENT or lebrikizumab impact on pSTAT6 in HVs. APG777 Phase 1
16 © Apogee Therapeutics, Inc. Single dose of APG777 led to deep and sustained TARC inhibition for ~3 months (limit of available follow - up) APG777 showed similar maximal inhibition of TARC compared to DUPIXENT but improved durability -30 -25 -20 -15 -10 -5 0 0 4 8 12 Weeks % TARC APG777 300 mg NOTE: These data are derived from different clinical trials conducted at different points in time, with differences in trial design , d osing regimen and patient populations. DUPIXENT data derived from a Phase 1 trial with 6 healthy volunteers receiving a single SC injection of 300 mg DUPIXENT. APG777 data derived from our Phase 1 trial in 6 healthy volunteers receiving a single SC injection of 300 mg of APG777. As a result, cross - trial comparisons cannot be made, and no head - to - head clinical trials have been conducted. APG777 is an investigational drug and has not been approved by the FDA as safe and effective. SOURCE: Li, Z , et al. ACCP, 2020. Data for time points on nominal day post dose 1, 29, 85. No data has been published showing lebrikizumab impact on TARC in HVs . Median % changes fro m baseline in TARC inhibition Median % changes fro m baseline in TARC inhibition -30 -25 -20 -15 -10 -5 0 0 4 8 12 Weeks % TARC DUPIXENT 300 mg APG777 Phase 1
APG777 Phase 2 in AD
18 © Apogee Therapeutics, Inc. APG777 Phase 2 regimen is designed to achieve two goals Induction Goal: Exceed lebrikizumab exposures Maintenance Goal: Equal lebrikizumab exposures Lebrikizumab data suggests an exposure - response for efficacy in induction There was no exposure - response observed in maintenance for lebrikizumab APG777 Phase 2
19 © Apogee Therapeutics, Inc. Lebrikizumab Ph3 subgroup with higher exposures had consistently better efficacy across key endpoints Efficacy of biologics in AD (Week 16, placebo - adjusted) 34 26 28 38 25 26 49 38 38 Responders, % EASI - 75 EASI - 90 IGA 0/1 DUPIXENT Ph3 Lebrikizumab Ph3, all patients (N = 851) Lebrikizumab Ph3, <60 kg subgroup (N = 180) NOTE: In lebrikizumab Ph2b and Ph3 there has been no dose - AE or exposure - AE relationship. Lebrikizumab exposures and efficacy ar e for the Phase 3 dose (500 mg Loading Dose at Weeks 0 and 2, 250 mg Q2W Weeks 4 to 16). Efficacy data are derived from different clinical trials at different points in time, with differences in trial design and pa tie nt populations. As a result, cross - trial comparisons cannot be made, and no head - to - head clinical trials have been conducted. SOURCE: Lebrikizumab European Public Assessment Report. DUPIXENT USPI. • Exposure - response in induction demonstrated by lebrikizumab • ~30% higher exposures in lebrikizumab low bodyweight subgroup led to improved efficacy across endpoints APG777 Ph2 Part A targets ~30 - 40% higher exposure than lebrikizumab in induction with ~50% fewer injections ~30% higher exposure in subgroup APG777 Phase 2
20 © Apogee Therapeutics, Inc. Lebrikizumab has demonstrated superior maintenance compared to DUPIXENT 72 54 82 77 Maintenance of response in AD (Week 52 ) Responders, % EASI - 75 IGA 0/1 • N o dose - response or exposure - response in maintenance was observed for lebrikizumab • Lebrikizumab has shown superior maintenance responses compared to DUPIXENT • Real - world data for DUPIXENT shows poor compliance; ~50% of patients discontinue before two years 3 APG777 maintenance regimens are designed to equal lebrikizumab exposures with only 2 - 4 injections per year (vs. 13 - 26 injections per year) DUPIXENT 1 Lebrikizumab 2 NOTE: The labeled dose of lebrikizumab is Q4W in maintenance. Efficacy data are derived from different clinical trials at different points in time, with differences in trial design and pa tie nt populations. As a result, cross - trial comparisons cannot be made, and no head - to - head clinical trials have been conducted. SOURCE: 1) Worm, M, et al, JAMA Derm, 2020. 2) Blauvelt, A et al Br J Dermatol, 2023. 3) Symons et al. AAD 2024 (poster prese nta tion) APG777 Phase 2
21 © Apogee Therapeutics, Inc. APG777 Phase 2 exposures are designed to exceed lebrikizumab in induction and equal in maintenance 2 - 4 vs 13 - 26 injections for lebrikizumab/DUPIXENT Modeled concentration of APG777 in induction and maintenance (Q3M) vs lebrikizumab APG777 Median 95% PI Lebrikizumab Median 95% PI NOTE: Every 3 - month maintenance dosing regimen shown. The above graph is illustrative only with respect to plans for dosing of A PG777 and does not present comparative data. 6 vs 10 - 11 injections for lebri/DUPIXENT Induction goal: Exceed lebri exposures by ~30 - 40% Maintenance goal: Equal lebri exposures 250 200 150 100 50 0 0 4 8 12 16 20 24 28 32 36 40 44 48 52 Time (weeks) Concentration ( μ g/mL) APG777 Phase 2
22 © Apogee Therapeutics, Inc. Phase 2 design is >90% powered in both Part A / B and has potential for significant acceleration Ongoing integrated Phase 2 trial expected to have 16 - week Part A topline data in 2H’25 Part A: Proof - of - concept (N ~110) Induction Maintenance Screening 2:1 Every 3 mos (Q12W) Every 6 mos (Q24W) W16 Primary Endpoint NOTE: Induction regimen in Part A is two injections (720mg) week 0 and week 2 followed by a single injection (360mg) at week 4 a nd 12. Number of and doses within induction and maintenance regimens to be tested in Part B are preliminary and will be confirmed ba sed on emerging data from Part A. Rollover to OLE or 52 - week follow - up period Part B: Dose optimization (N ~360) Screening 1:1:1:1 Regimen A (TBD) Rollover to OLE or 52 - week follow - up period High Dose Medium Dose Low Dose Placebo Maintenance Induction W16 Primary Endpoint Regimen B (TBD) APG777 Phase 2 Induction regimen Placebo
23 © Apogee Therapeutics, Inc. Phase 2 16 - week Part A induction data in atopic dermatitis is planned to readout in 2H 2025 Safety Efficacy primary endpoint Efficacy key secondary endpoints Confirm well tolerated safety profile as seen in Phase 1 HV study and in line with other agents in class (e.g., DUPIXENT, lebrikizumab) OBJECTIVES Primary endpoint of percent change from baseline in EASI at Week 16 in line with standard of care (approx. 65 - 70% topline) Proportion of patients achieving key secondary endpoints at Week 16 (future approvable endpoints) in line with standard of care: • EASI - 75: approx. 45 - 50% (topline) • IGA 0/1: approx. 35 - 40% ( topline ) NOTE: 1 Based on FDA label for DUPIXENT Œ APG777 Phase 2
24 © Apogee Therapeutics, Inc. Strong historical correlation between Ph2 and Ph3 data makes APG777 16 - week induction data a key catalyst SOURCE: Ph3 data for DUPIXENT, RINVOQ, and CIBINQO is from USPI. 1) Guttman - Yassky E et al J All Clin Immunol. 2020. 2) Gooderham MJ et al JAMA Dermatol . 2019. 3) Guttman - Yassky E et al JAMA Dermatol. 2020. 4) Silverberg JI et al. NEJM 2023 5) Thaci et al. Lancet 2016 . 6) Agnihotri, G., et al. Clin Drug Investig 2020 0 10 20 30 40 50 60 70 80 90 100 0 10 20 30 40 50 60 70 80 90 100 RINVOQ 15mg QD 1 DUPIXENT 300mg Q2W 5 RINVOQ 30mg QD 1 CIBINQO 100mg QD 2 CIBINQO 200mg QD 2 Lebrikizumab 250mg Q2W 3,4 Pbo - adjusted EASI - 75 Phase 3 Pbo - adjusted EASI - 75 Phase 2 Biologic Note: While JAKi efficacy held up from Ph2 to Ph3, FDA applied a boxed warning to the class due to increased risk of CV events and death; patients must step through biologic to get to JAKi JAK inhibitor Strong correlation between Phase 2 and 3 results in AD for validated endpoint EASI - 75 Phase 3 failure in AD is rare A 2020 review examining failed trials for AD did not find any completed, placebo - controlled Phase 3s that did not meet the primary endpoint 6 APG777 Phase 2
Potential first - in - class combination therapy in atopic dermatitis
26 © Apogee Therapeutics, Inc. AD is heterogenous – Type 2 is the core pathway with varying involvement of Type 1 and Type 3 Severity Age Ethnicity Moderate Severe Type 2 Type 3 Type 1 Pediatric Adult Type 2 Type 3 Type 1 Asian European Type 2 Type 3 Type 1 SOURCE: Adapted from Fania et al. Int. J. Mol. Sci. 2022. 777+990
27 © Apogee Therapeutics, Inc. OX40L / OX40 interaction drives Type 1, 2, and 3 inflammation in atopic dermatitis NOTE: Amlitelimab biomarker changes presented are average values across dose cohorts based on approximate data points from di git ized charts. APC = antigen presenting cell SOURCE: Sanofi 2023 R&D day presentation • OX40L is expressed on antigen - presenting cells (APCs) • OX40L / OX40 interaction promotes inflammatory T cell responses in AD • T cells produce Type 1, 2, and 3 cytokines that drive inflammation and AD symptoms • Type 2 (IL - 13) is the core pathway in AD; Type 1 and 3 play a secondary role in specific subpopulations Blocking OX40L / OX40 interaction has the potential to broadly inhibit Type 1, 2, and 3 inflammation 777+990 OX40L OX40 APC T cell Type 1 Type 2 Type 3 IFNγ IL - 13 IL - 22 TNF ⍺ IL - 17 Cytokine response
28 © Apogee Therapeutics, Inc. OX40L inhibition is clinically validated in AD and has demonstrated broad cytokine suppression Upcoming amlitelimab (OX40L) POC readouts Atopic dermatitis PoC achieved Asthma Ph2b data in H2 2024 Hidradenitis suppurativa (0.4M eligible patient pop.) Ph2 data in 2025 Alopecia areata (0.6M eligible patient pop.) Ph2 data in 2025 Celiac disease (0.2M eligible patient pop.) Ph2 start in 2024 Systemic sclerosis (0.2M eligible patient pop.) Ph2 start in 2024 Indication wher e IL - 13 / IL - 4R ⍺ inhibition also achieved PoC NOTE: Eligible patient population for each indication is based on Sanofi estimates specific to amlitelimab SOURCE: Sanofi 2023 R&D day presentation IL - 13 IL - 17A IL - 22 Biomarker % reduction from baseline (PBO - adj) - 40% - 63% - 62% Type 3 Type 2 Potential additional benefit from deeper inhibition of Type 2 inflammation Amlitelimab (OX40L) Phase 2b AD biomarker data 777+990
29 © Apogee Therapeutics, Inc. APG990 leverages amlitelimab’s mechanism to deliver a potentially best - in - class, pipeline - in - a - product antibody 4.5 6.5 7.8 4.7 OX40 signaling OX40 binding IC 90 (nM) APG990 epitope overlaps with amlitelimab to leverage proven MoA APG990 is as potent as amlitelimab across preclinical assays APG990 NHP half - life is extended relative to amlitelimab NOTE: MoA = Mechanism of Action. 106 71 OX40L affinity APG990 Amlitelimab IC 90 (nM) K D (pM) 2.9 2.3 IL - 2 APG990 Concentration Days 26 vs 21 days Amlitelimab IL - 2 release APG990 Amlitelimab Human OX40L APG990 Phase 1 initiation planned for Q3 2024 777+990
30 © Apogee Therapeutics, Inc. Potential first - in - class APG777+APG990 combo targets all inflammatory types, including full Type 2 inhibition NOTE: Amlitelimab biomarker changes presented are average values across dose cohorts based on approximate data points from di git ized charts. APC = antigen presenting cell SOURCE: Sanofi 2023 R&D day presentation • APG990 targets upstream OX40L/OX40 interaction • Potential for Type 1, 2 and 3 inhibition without safety / tolerability issues associated with JAK inhibitors • APG777 targets downstream IL - 13 • APG777 Phase 1 demonstrated near complete inhibition of Type 2 inflammatory biomarker pSTAT6 APG777+APG990 combination enables potentially best - in - class efficacy and dosing (Q3M+) 777+990 OX40L APG990 T cell APC Type 1 Type 2 Type 3 APG777 Reduced cytokine response IFNγ IL - 13 IL - 22 TNF ⍺ IL - 17
31 © Apogee Therapeutics, Inc. IL - 13 and OX40L are the two orthogonal mechanisms with greatest efficacy in AD Target IL - 13 1,2 IL - 4R α 3 OX40L 4 IL - 22R 5 IL - 31R 6 TSLP 7 IL - 22 8 Agent Lebrikizumab (high - exposure) Lebrikizumab Amlitelimab LEO138559 Nemolizumab Fezakinumab Inflammation targeted Type 2 Type 2 Type 1, 2, 3 Type 3 Type 2 Type 2, 3 Type 3 EASI - 75 % responders pbo adjusted IGA(0,1) % responders pbo adjusted 49 38 34 38 26 28 Not available Approved In development Terminated Status in AD Selected targets for 777+990 combination We are combining two of the most active and orthogonal MOAs with potential to exceed monotherapy efficacy 29 28 13 15 17 20 11 17 10 777+990 NOTE: MOA = Mechanism of Action. Tezspire and nemolizumab results are from combination trials with TCS. Fezakinumab data is from week 20 while all others are week 16. Lebrikizumab, DUPIXENT, and nemolizumab values reflect the weighted average from phase 3 trials, all other values are from Ph2 trials. Nemolizumab is approved in Japan for itch associated with AD and marketed as Mitchga . Lebrikizumab is approved in the EU under the marketed name Ebglyss. SOURCE: 1. Silverberg J et al. NEJM. (2023). 2. Ebglyss EMA Public Assess men t Report. 3. Simpson E at al. NEJM. (2016) 4. Weidinger S et al. EADV oral presentation (2023). 5.Thaci et al. AAD oral presentation (2023). 6. Silverberg J. EADV oral presentation (2023) 7. Simpson E et al. J Am Acad Dermatol. (2019). 8. Guttman - Yassky E et al. J Am Acad Dermatol.(2018)
32 © Apogee Therapeutics, Inc. Targeting all inflammatory types may provide greater efficacy Efficacy of advanced systemics in AD (Week 16, placebo - adjusted) 29 34 38 49 EASI - 75 Responders, % Amlitelimab, Ph2b (250mg Q4W +LD) DUPIXENT Ph3 Lebrikizumab Ph3, all patients (N = 851) Lebrikizumab Ph3, <60 kg subgroup (N = 180) RINVOQ Ph3, 30mg NOTE: In lebrikizumab Ph2b and Ph3 there has been no dose - AE or exposure - AE relationship. Lebrikizumab exposures and efficacy ar e for the Phase 3 dose (500 mg Loading Dose at Weeks 0 and 2, 250 mg Q2W Weeks 4 to 16). Efficacy data are derived from different clinical trials at different points in time, with differences in trial design and pa tie nt populations. As a result, cross - trial comparisons cannot be made, and no head - to - head clinical trials have been conducted. SOURCE: Lebrikizumab European Public Assessment Report. DUPIXENT USPI. RINVOQ USPI. Weindinger , S. Oral Presentation. AAD (2024). • JAKs inhibit Type 1, 2 and 3 inflammation but carry a black box warning limiting uptake • DUPIXENT and lebrikizumab block Type 2 inflammation • Amlitelimab partially inhibits Type 1, 2, and 3 inflammation with an acceptable safety profile APG777 shows near complete inhibition Type 2 inflammation – the core driver of AD APG990 provides potential for broader inhibition to also address heterogenous Type 1 and Type 3 inflammation in AD 777+990 62
Potential best - in - class combination therapies in asthma and COPD
34 © Apogee Therapeutics, Inc. 0 10 20 30 40 50 60 70 80 90 100 0 2 4 6 8 10 12 Dosing Interval (weeks) Tezepelumab asthma ITT Mepolizumab asthma ≥150 Benralizumab asthma ≥300 Apogee is pursuing potentially best - in - class combinations in respiratory diseases Reduction in asthma exacerbations Potential for best - in - class efficacy APG990 / APG333 APG777 / APG808 Respiratory Potential for every 2 - to - 3 - month maintenance dosing NOTE: AER = Annualized Exacerbation Rate. These data are derived from different clinical trials conducted at different points in time, with differences in trial design , dosing regimen and patient populations. DUPIXENT label indicates reductions in exacerbations were significant in those with eos ≥150. TEZSPIRE data from population without a biomarker requirement. NUCALA data from population with eos ≥150 at screening or ≥300 in prior year. FASENRA data from two Phase 3 trials in patients with eos ≥300. DUPIXENT COPD data reflective of two Ph3 trials in patients with eos ≥300. TEZSPIRE COPD data shown for patients with eos ≥150. SOURCE: EvaluatePharma , FDA labels DUPIXENT (Ph3) and TEZSPIRE (Ph2) have shown lower AER reductions in COPD patients $4.6B (Approved 2018) Estimated WW peak sales in asthma and approval year $3.1B (Approved 2021) $2.3B (Approved 2015) $2.0B (Approved 2017)
35 © Apogee Therapeutics, Inc. - 40 - 30 - 20 - 10 - 50 Phase 2a 1 QUEST 2 Placebo - adjusted FeNO change (ppb) PATHWAY 4 NAVIGATOR 5 SOURCE 6 MILLY 7 LUTE/VERSE 8 MESOS 9 Phase 1b 10 VENTURE 3 Respiratory Recent data has suggested combo inhibition can lead to additive efficacy in respiratory indications Anti - IL - 4R ⍺ trials Anti - TSLP trials Anti - IL - 13 trials Combined blockade of Type 2 inflammation through IL - 13 inhibition and disrupted alarmin signaling by TSLP neutralization demonst rates a potential increase in effect not previously seen by monotherapies alone Anti - IL - 13 + Anti - TSLP trial NOTE: FeNO level reflects data from marketed dose, where available. Data shown is placebo - adjusted reduction at 29d, with the exception of QUEST, where level was reported at 12 weeks. LUTE/VERSE data from was periostin - high enrollees. SOURCE: 1) Wenzel S, et al. NEJM, 2013 2) Castro M, et al. NEJM, 2018 3) Rabe KF et al. NEJM, 2018 4) Corren JC, et al. NEJM, 2017 5) Menzies - Gow A, et al. NEJM, 2021 6) Weschler M, et al. Lancet Respir Med, 2022 7) Corren JC, et al. NEJM., 2011 8) Hanania NA, et al. Thorax, 2015 9) Russell RJ, et al. Lancet Respir Med, 2018 10) Deiteren A, et al. ATS, 2023
36 © Apogee Therapeutics, Inc. Apogee’s portfolio uniquely enables multiple combos with best - in - class potential in respiratory indications Only known portfolio with IL - 13, IL - 4R ⍺ , OX40L, and TSLP inhibitors to enable optimal respiratory combination approaches Potential to bring Q3M+ dosing to an IL - 13 / TSLP combo approach that has been validated by 3 rd party data Potential for deeper and broader responses by targeting orthogonal mechanisms Potential for best - in - class dosing via coformulation approach Respiratory APG777 / APG808 APG990 / APG333
37 © Apogee Therapeutics, Inc. Apogee’s TSLP combinations have potential to exceed monotherapy efficacy in a broader population Differentiators APG777 in asthma APG808 in COPD APG777+APG333 in asthma Best - in - class combo in COPD Potential patient population (% eligible) High EOS Potential for broader population Based on TSLP MoA + data in all - comers asthma Potential efficacy advantage TBD, based on optimizing exposure IL - 13+TSLP has demonstrated additive FeNO benefit Potential to exceed monotherapy ceiling Respiratory Potential best - in - class combos with TSLP Potential monotherapies without TSLP
38 © Apogee Therapeutics, Inc. APG808 leverages DUPIXENT's mechanism to deliver a potentially best - in - class, pipeline - in - a - product antibody 1.1 1.3 1.9 1.7 STAT6 TARC IC 90 (nM) APG808 Concentration Time 26 vs 12 days Human IL - 4R α APG808's epitope on IL - 4R α overlaps with DUPIXENT’s and leverages proven MoA and biology APG808 is as potent as DUPIXENT across preclinical assays APG808 NHP half - life is more than 2x longer than DUPIXENT NOTE: MoA = Mechanism of Action. 12.0 0.4 IL - 4Rα affinity APG808 DUPIXENT APG808 DUPIXENT IC 90 (pM) K D (pM) 249 224 TF - 1 DUPIXENT APG808
39 © Apogee Therapeutics, Inc. APG808 Phase 1a clinical trial objectives Confirm tolerable safety profile Establish optimized PK profile with a half - life of at least 42 days Determine dosing regimens to sustain exposures similar to DUPIXENT OBJECTIVES APG808 Dosing Goal: every 6 - or 8 - weeks (vs. every 2 weeks for DUPIXENT 1 ) Q4 2024: confirm potential for best - in - class dosing intervals NOTE: PK = Pharmacokinetic. 1 Based on FDA label for DUPIXENT Œ
Expansion indications
41 © Apogee Therapeutics, Inc. Dermatology AD AA PN BP HS Pulmonology / Immunology Asthma 1 COPD 1 CRSwNP CSU AR 2 ColdU CPUO Food allergy SS Gastroenterology EoE Celiac Disease EGID UC 1 Planned Apogee Ph2 based on well - established mechanism 3 rd party clinical data supporting one or more Apogee targets Ongoing 3 rd party clinical trials which could validate one or more Apogee targets Expansion Our programs have broad potential to disrupt the I&I space NOTE: 1 Eosinophilic subtypes 2 Perennial AA = Alopecia Areata. PN = Prurigo Nodularis . BP= Bullous Pemphigoid. HS = hidradenitis suppurativa. CSU = Chronic Spontaneous Urticaria. CRSwNP = Chronic Rhinosinusitis with Nasal Polyps ColdU = Cold Inducible Urticaria. CPUO = Chronic Pruritis of Unknown Origin. . AR = Allergic Rhinitis. SS= Systemic Sclerosis. EoE = Eosinophilic esophagitis. UC = Ulcerative Colitis. EGID = Eosinophilic Gastrointestinal Disorders (non - EoE ) . Potential blockbuster expansion
42 © Apogee Therapeutics, Inc. We are pursuing the largest markets in I&I with a total addressable population over 300M WW addressable patient population across indications (in millions) Indication NOTE: AD = Atopic Dermatitis, COPD = Chronic Obstructive Pulmonary Disease, CSU = Chronic Spontaneous Urticaria, CRSwNP = Chr oni c Rhinosinusitis with Nasal Polyps, EoE = Eosinophilic Esophagitis, PN = Prurigo Nodularis, AA = Alopecia Areata, EGID = Eosinophilic Gastrointestinal Disorders (non - EoE ), AR = Allergic Rhinitis. 1 Encompasses moderate - to - severe population. 2 Encompasses prevalent population. SOURCE: Academic journals, disease foundations, WHO, CDC, census data , analyst research, EvaluatePharma. 2030E market size rounded to nearest $0.5B. Current pursued indications Expansion opportunities 2030E Market Size $29.0B $20.0B $13.5B $4.5B $1.0B $2.0B $0.5B $0.5B TBD $70B++ PN 2 AD 1 65.5 EoE 2 Asthma 1 TBD EGID & AR Total WW Addressable Population 59.6 COPD 1 64.4 CSU 2 60.3 CRSwNP 2 6.1 AA 2 3.8 81.6 300M+ 2.8 Expansion
Corporate & Commercial
44 © Apogee Therapeutics, Inc. Michael Henderson, MD Chief Executive Officer, Director Carl Dambkowski, MD Chief Medical Officer Jane Pritchett Henderson Chief Financial Officer Rebecca Dabora, PhD Chief Development Officer Matt Batters, JD Chief Legal Officer Wendy Aspden - Curran SVP of Clinical Operations Drew Badger, PhD SVP of Regulatory Affairs & Toxicology Dan Mulreany SVP of Business Development & Strategy Kristine Nograles, MD, MSc SVP of Clinical Development Corporate Experienced team with proven history of clinical development and commercial execution
45 © Apogee Therapeutics, Inc. Michael Henderson, MD CEO, Apogee Therapeutics Mark McKenna Chairman & CEO, Mirador Therapeutics Jennifer Fox CFO & CBO, Zenas BioPharma Andrew Gottesdiener, MD Venrock Corporate Board of Directors with industry - leading development, regulatory, commercial and management expertise BJ Jones CCO, NewAmsterdam Pharma Peter Harwin Managing Member, Fairmount Tomas Kiselak Managing Member, Fairmount Nimish Shah Venrock Lisa Bollinger, MD CEO & President of Bollinger Regulatory Consulting, LLC
46 © Apogee Therapeutics, Inc. Analog Differentiation Peak Market Share Corresponding Peak Sales in the potentially $50B AD Market Apogee’s Path Potential for APG777 to be the first No known analogs have best - in - class dosing and efficacy ~$17B+ APG777 has the potential to “win the day” with anticipated best - in - class dosing and efficacy Skyrizi is primarily differentiated by its quarterly dosing profile ~$17B Apogee’s path to dosing differentiation is de - risked by its potential best - in - class PK Relatively undifferentiated ~$5B Apogee’s existing data suggest an already differentiated profile making this case unlikely APG777 could command #1 market share in the potentially $50B+ AD market SOURCE: EvaluatePharma “Skyrizi of AD” base case suggests ~ $ 17 B revenue potential for APG777; significant upside to revenue potential if efficacy advantage is demonstrated Increasing differentiation Commercial ~8 to 10% ~33% Potential for 33%+
47 © Apogee Therapeutics, Inc. Corporate Multiple anticipated milestones through 2025 with $790M in cash providing expected runway into 2028 Potential best - in - class monotherapy in AD APG777 IL - 13 ✓ Positive Phase 1 PK & safety in HVs ✓ 1H: Phase 2 initiated in AD • 2H: Phase 2 16 - week induction PoC data • Disclose additional indication Potential best - in - class mAbs for combinations APG808 IL - 4R α ✓ Phase 1 initiated in HVs • 4Q: Initial Phase 1 PK & safety in HVs • 1H: Phase 1b clinical data in asthma APG990 OX40L ✓ Candidate nomination • 3Q: Phase 1 initiation in HVs • Initial Phase 1 PK & safety in HVs APG333 TSLP • Candidate nomination • Phase 1 initiation in HVs Potential first - or best - in - class combination approaches APG777 ± APG990 IL - 13 ± OX40L • Clinical trial initiation in AD APG777 ± APG333 IL - 13 ± TSLP Additional combination(s) IL - 13/IL - 4R α + OX40L/TSLP • 4Q: Additional respiratory combination(s) to be announced at R&D Day in December 2025 2024 NOTE: As of June 30, 2024, Apogee had cash, cash equivalents and marketable securities of $790M. Key readout
Apogee /ˈ apəjē / noun The highest point in the development of something; a climax or culmination