Full Press Release Details
Pipeline programs continue to advance, with four clinical data readouts anticipated in 2026; APG777 trial readout timelines accelerated, with Phase 1b in asthma and APEX 52-week Part A data in AD anticipated in Q1 2026, APEX 16-week Part B data in AD in Q2 2026, and APG279 Phase 1b head-to-head readout against DUPIXENT in AD in 2H 2026
Interim Phase 1 results of APG333 in healthy volunteers reported today exceeded trial objectives, demonstrated a half-life of approximately 55 days, and suppressed key biomarkers for 6 months following a single dose, supporting potential 3- and 6-month dosing and the development of a quarterly or less frequently dosed co-formulation of APG273 (APG777+APG333) for respiratory indications
Completed $345 million public offering; $913million cash, cash equivalents and marketable securities pro forma as of September 30thsupports runway into 2H 2028
SAN FRANCISCO and BOSTON, Nov. 10, 2025 (GLOBE NEWSWIRE) -- Apogee Therapeutics, Inc., (Nasdaq: APGE), a clinical-stage biotechnology company advancing optimized, novel biologics with potential for best-in-class profiles in the largest inflammatory and immunology (I&I) markets, today provided pipeline progress and reported third quarter 2025 financial results.
“Apogee is gearing up for a potentially transformative 2026 from a position of strength. With four key readouts coming in 2026 and the recent financing providing us runway through Phase 3 topline data for our lead program, APG777 in atopic dermatitis, we believe we are well positioned to advance our therapies to patients as quickly as possible,” said Michael Henderson, M.D., Chief Executive Officer of Apogee. “In conjunction with our third quarter results, we are pleased to share first-in-human data for APG333, which, together with APG777, we believe could prove to be a best-in-class combination approach for respiratory indications, with the potential for dosing every three months or even less frequently. As we move into 2026, we look forward to advancing APG777’s pipeline-in-a-product potential, beginning with the Phase 1b proof-of-concept readout in patients with asthma, followed by the Phase 2 Part A maintenance data in AD in the first quarter; Phase 2 Part B data in AD in the second quarter; and results from the APG279 Phase 1b head-to-head readout against DUPIXENT in AD in the second half of the year.”
Corporate & Pipeline Highlights and Upcoming Milestones
Third Quarter 2025 Financial Results
About ApogeeApogee Therapeutics is a clinical-stage biotechnology company advancing optimized, novel biologics with potential for best-in-class profiles 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 visithttps://apogeetherapeutics.com.
Forward Looking StatementsCertain 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 its clinical trials, including the Phase 1b in asthma, APEX 52-week Part A in AD, APEX 16-week Part B in AD, and APG279 Phase 1b head-to-head readout against DUPIXENT in AD; 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, APG273, APG990, APG333, and 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 commercialization; and its expectations regarding the time period over which Apogee’s capital resources will be sufficient to fund 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 Form 10-K for the year ended December 31, 2024, filed with the SEC on March 3, 2025, Quarterly Report on Form 10-Q for the quarterly period ended March 31, 2025, filed with the SEC on May 12, 2025, Quarterly Report on Form 10-Q for the quarterly period ended June 30, 2025, filed with the SEC on August 11, 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 SHEETS1(UNAUDITED)(In thousands, except share data) | ||||||||
| SEPTEMBER 30,2025 | DECEMBER 31,2024 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 107,914 | $ | 141,789 | ||||
| Marketable securities | 419,375 | 378,864 | ||||||
| Prepaid expenses and other current assets | 12,808 | 9,060 | ||||||
| Total current assets | 540,097 | 529,713 | ||||||
| Long-term marketable securities | 61,640 | 210,416 | ||||||
| Property and equipment, net | 6,032 | 1,959 | ||||||
| Right-of-use asset, net | 9,646 | 11,365 | ||||||
| Other non-current assets | 8,744 | 498 | ||||||
| Total assets | $ | 626,159 | $ | 753,951 | ||||
| Liabilities and stockholders' equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 376 | $ | 1,071 | ||||
| Lease liability | 4,079 | 3,234 | ||||||
| Accrued expenses and other current liabilities | 29,592 | 24,255 | ||||||
| Total current liabilities | 34,047 | 28,560 | ||||||
| Long-term liabilities: | ||||||||
| Lease liability, net of current | 5,774 | 8,597 | ||||||
| Total liabilities | 39,821 | 37,157 | ||||||
| Stockholders' equity: | ||||||||
| Common Stock; $0.00001 par value, 400,000,000 authorized, 60,147,727 issued and 59,315,738 outstanding as of September 30, 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 | 1,077,681 | 1,021,794 | ||||||
| Accumulated other comprehensive income | 1,028 | 915 | ||||||
| Accumulated deficit | (492,372 | ) | (305,916 | ) | ||||
| Total stockholders’ equity | 586,338 | 716,794 | ||||||
| Total liabilities and stockholders’ equity | $ | 626,159 | $ | 753,951 |
_________________1Note that Condensed Consolidated Balance Sheet as of September 30, 2025, excludes the impact of the October 2025 underwritten public equity offering.
| APOGEE THERAPEUTICS, INC.CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS(UNAUDITED)(In thousands) | ||||||||||||||||
| THREE MONTHS ENDEDSEPTEMBER 30, | NINE MONTHS ENDEDSEPTEMBER 30, | |||||||||||||||
| 2025 | 2024 | 2025 | 2024 | |||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | $ | 54,178 | $ | 45,714 | $ | 156,268 | $ | 107,636 | ||||||||
| General and administrative | 17,100 | 12,972 | 51,271 | 33,353 | ||||||||||||
| Total operating expenses | 71,278 | 58,686 | 207,539 | 140,989 | ||||||||||||
| Loss from operations | (71,278 | ) | (58,686 | ) | (207,539 | ) | (140,989 | ) | ||||||||
| Other income, net: | ||||||||||||||||
| Interest income, net | 6,318 | 9,668 | 21,299 | 26,061 | ||||||||||||
| Total other income, net | 6,318 | 9,668 | 21,299 | 26,061 | ||||||||||||
| Net loss before taxes | (64,960 | ) | (49,018 | ) | (186,240 | ) | (114,928 | ) | ||||||||
| Provision for income taxes | (61 | ) | — | (216 | ) | — | ||||||||||
| Net loss after taxes | $ | (65,021 | ) | $ | (49,018 | ) | $ | (186,456 | ) | $ | (114,928 | ) | ||||