Full Press Release Details
Apogee Therapeutics Provides Pipeline Progress
and Reports Full Year 2024 Financial Results
Accelerated execution of Phase 2 APEX clinical
trial for APG777, with Part A over-enrolled and Part B initiated ahead of schedule; topline Part A 16-week data expected mid-2025
APG279 (APG777 + APG990) Phase 1b head-to-head
study vs. DUPIXENT supported by positive APG990 interim Phase 1 results, which exceeded trial objectives and demonstrated potential for
three- and six-month dosing in combination with APG777; APG279 readout expected in second half of 2026
$731.1 million cash, cash equivalents and marketable
securities with runway into Q1 2028
San Francisco and Boston, March 3, 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 pipeline
progress and reported full year 2024 financial results.
"We achieved significant progress across
our pipeline in 2024 and are well-positioned to continue executing rapidly on our mission to bring transformative, potentially best-in-class
therapies to patients with I&I diseases," said Michael Henderson, M.D., Chief Executive Officer of Apogee. "We kicked
off 2025 by over-enrolling Part A and dosing the first patient in the Part B portion of our Phase 2 APEX clinical trial for APG777 in
AD, well ahead of schedule and we are on track for our critical 16-week readout for APG777 in mid-2025. Our positive readout today from
the Phase 1 trial of APG990 in healthy volunteers enables our combination study of APG777 + APG990, which we have named APG279, versus
DUPIXENT this year following regulatory submissions, with this important dataset expected in the second half of 2026. With a strong cash
position and several meaningful catalysts expected, we are looking forward to an exciting and productive 2025."
Pipeline Highlights and Upcoming Milestones
Full Year 2024 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), the Phase 1b and 2b trials of APG777
in asthma, the Phase 2 trial of APG777 in EoE, and the Phase 1b trial of APG333 in asthma; the expected timing of and results from its
clinical trials, including data from its Phase 2 trial of APG777, Phase 1b trial of APG279, Phase 1 trial of APG333, Phase 1b trial of
APG808, the potential combination of APG777 and APG333; planned clinical trial designs; its plans for current and future clinical trials;
the potential clinical benefit and half-life of APG777, APG990, APG333, APG808, Apogee's other product candidates, including combination
therapies, and any other potential programs; its expected timing for future pipeline updates and expectations regarding the time period
over which Apogee's capital resources will be sufficient to funds its anticipated operations. Words such as "may," "might,"
"will," "objective," "intend," "should," "could," "can," "would,"
"expect," "believe," "design," "estimate," "predict," "potential,"
"develop," "plan" or the negative of these terms, and similar expressions, or statements regarding intent, belief,
or current expectations, are forward-looking statements. While Apogee believes these forward-looking statements are reasonable, undue
reliance should not be placed on any such forward-looking statements, which are based on information available to the company on the date
of this release. These forward-looking statements are based upon current estimates and assumptions and are subject to various risks and
uncertainties (including, without limitation, those set forth in Apogee's filings with the U.S. Securities and Exchange Commission
(the SEC)), many of which are beyond the company's control and subject to change. Actual results could be materially different.
Risks and uncertainties include: global macroeconomic conditions and related volatility, expectations regarding the initiation, progress,
and expected results of Apogee's preclinical studies, clinical trials and research and development programs; expectations regarding
the timing, completion and outcome of Apogee's clinical trials; the unpredictable relationship between preclinical study results
and clinical study results; the timing or likelihood of regulatory filings and approvals; liquidity and capital resources; and other risks
and uncertainties identified in Apogee's Quarterly Report on 10-Q for the quarterly period ended September 30, 2024, filed with
the SEC on November 12, 2024, and subsequent disclosure documents the company may file with the SEC. Apogee claims the protection of the
Safe Harbor contained in the Private Securities Litigation Reform Act of 1995 for forward-looking statements. Apogee expressly disclaims
any obligation to update or alter any statements whether as a result of new information, future events or otherwise, except as required
APOGEE THERAPEUTICS, INC.
CONSOLIDATED BALANCE SHEETS
(In thousands, except unit/share data)
| DECEMBER 31, 2024 | DECEMBER 31, 2023 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 141,789 | $ | 118,316 | ||||
| Marketable securities | 378,864 | 277,143 | ||||||
| Prepaid expenses and other current assets | 9,060 | 2,950 | ||||||
| Total current assets | 529,713 | 398,409 | ||||||
| Long-term marketable securities | 210,416 | - | ||||||
| Property and equipment, net | 1,959 | 377 | ||||||
| Right-of-use asset, net | 11,365 | 2,217 | ||||||
| Other non-current assets | 498 | 401 | ||||||
| Total assets | $ | 753,951 | $ | 401,404 | ||||
| Liabilities and stockholders' equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 1,071 | $ | 2,143 | ||||
| Lease liability | 3,234 | 1,101 | ||||||
| Accrued expenses | 24,255 | 17,314 | ||||||
| Total current liabilities | 28,560 | 20,558 | ||||||
| Long-term liabilities: | ||||||||
| Lease liability, net of current | 8,597 | 933 | ||||||
| Total liabilities | 37,157 | 21,491 | ||||||
| Stockholders' equity: | ||||||||
| Common Stock; $0.00001 par value, 400,000,000 authorized, 59,478,725 issued and 58,062,898 outstanding as of December 31, 2024; 400,000,000 authorized, 50,655,671 issued and 48,338,769 outstanding as of December 31, 2023 | 1 | - | ||||||
| Additional paid-in capital | 1,021,794 | 503,354 | ||||||
| Accumulated other comprehensive income | 915 | 329 | ||||||
| Accumulated deficit | (305,916 | ) | (123,770 | ) | ||||
| Total stockholders' equity | 716,794 | 379,913 | ||||||
| Total liabilities and stockholders' equity | $ | 753,951 | $ | 401,404 |
APOGEE THERAPEUTICS, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS
| YEAR ENDED DECEMBER 31, | ||||||||
| 2024 | 2023 | |||||||
| Operating expenses: | ||||||||
| Research and development | $ | 167,865 | $ | 68,424 | ||||
| General and administrative | 49,005 | 24,579 | ||||||
| Total operating expenses | 216,870 | 93,003 | ||||||
| Loss from operations | (216,870 | ) | (93,003 | ) | ||||
| Other income, net: | ||||||||
| Interest income, net | 34,742 | 9,018 | ||||||
| Total other income, net | 34,742 | 9,018 | ||||||
| Net loss before taxes | (182,128 | ) | (83,985 | ) | ||||
| Provision for income taxes | (18 | ) | - | |||||
| Net loss after taxes | $ | (182,146 | ) | $ | (83,985 | ) |
VP, Investor Relations
Apogee Therapeutics, Inc.