Full Press Release Details
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
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
"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
First Quarter 2025 Financial Results
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
(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
| 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 | ) |
VP, Investor Relations
Apogee Therapeutics, Inc.