Phase 1 clinical trial of APG777, a fully optimized, subcutaneous, extended half-life anti-IL-13 antibody, initiated ahead of schedule with initial PK and safety data from healthy volunteers expected mid-2024; on track to begin Phase 2 in moderate-to-severe atopic dermatitis in 2024
Announcing our finalized nomination of development candidate for APG808, a potentially best-in-class, femtomolar affinity, subcutaneous extended half-life antibody targeting IL-4Rα, a target with clinical validation across eight Type 2 allergic diseases in 4Q 2023
Well-capitalized with $422.9 million in cash following upsized IPO supporting operating runway into 4Q 2026
SAN FRANCISCO and WALTHAM, Mass., Nov. 13, 2023 (GLOBE NEWSWIRE) — Apogee Therapeutics, Inc. (Nasdaq: APGE), a clinical-stage biotechnology company advancing differentiated biologics for the treatment of atopic dermatitis (AD), asthma, chronic obstructive pulmonary disease (COPD) and other inflammatory and immunology (I&I) indications, today provided business updates and reported third quarter 2023 financial results.
“I am proud of our team’s execution during the third quarter and 2023 overall. We continue to deliver against our operating plan, advancing our lead program, APG777 for AD, into a first-in-human healthy volunteer study ahead of schedule while progressing our portfolio of potentially best-in-class biologics designed to significantly improve therapeutic options for patients across the largest markets in I&I”, said Michael Henderson, M.D., Chief Executive Officer of Apogee. “We expect to report initial PK and safety data from the Phase 1 trial for APG777 in mid-2024, a potentially key de-risking milestone, which we believe could demonstrate our potential benefit relative to the current standard of care, including optimized exposures, low variability, and extended half-life. Alongside the advancements in APG777, we are excited to announce the selection of a development candidate for our second program, APG808, and remain on track to enter the clinic in healthy volunteers in 2024 followed by a Phase 2 trial in COPD.
Pipeline Highlights and Upcoming Milestones
Apogee expects initial safety and PK data from the Phase 1 trial in mid-2024, a potentially key de-risking milestone given APG777 is targeting a validated mechanism. The goal of the Phase 1 trial is to support potential dosing every 2 to 3 months compared to the current standard of care of every 2 to 4 weeks. Apogee believes this potential for significant differentiation compared to leading therapies may contribute to a best-in-class profile for APG777. Pending positive PK and safety data, the company plans to advance into a randomized, double-blind, placebo-controlled, 16-week Phase 2 proof-of-concept trial in moderate-to-severe patients with AD in 2024 with data expected in the second half of 2025.
Recent Corporate Highlights
Upcoming Investor Events
Apogee plans to participate in the following upcoming events:
Third Quarter Financial Results
About Apogee
Apogee Therapeutics is a clinical-stage biotechnology company seeking to develop differentiated biologics for the treatment of atopic dermatitis (AD), asthma, chronic obstructive pulmonary disease (COPD) and other inflammatory and immunology indications with high unmet need. 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. The company’s two most advanced programs are APG777 and APG808, which are being initially developed for the treatment of AD and COPD, respectively. 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.
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, our expectations regarding plans for our current and future product candidates and programs, plans for our current and future clinical trials, plans for clinical trial design, the anticipated timing of the initiation of and results from our clinical trials, potential clinical benefit and half-life of APG777, APG808 and any other potential programs, and expectations regarding the time period over which our capital resources will be sufficient to fund our 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 our preclinical studies, clinical trials and research and development programs; expectations regarding the timing, completion and outcome of our 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 our Quarterly Report of 10-Q for the quarterly period ended June 30, 2023, filed with the SEC on August 28, 2023, 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.
APOGEE THERAPEUTICS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS |
||||||||
SEPTEMBER 30, | DECEMBER 31, | |||||||
2023 | 2022 | |||||||
Assets | ||||||||
Current assets: | ||||||||
Cash and cash equivalents | $ | 188,269 | $ | 151,890 | ||||
Marketable securities | 234,585 | – | ||||||
Prepaid expenses and other current assets | 3,567 | 165 | ||||||
Total current assets | 426,421 | 152,055 | ||||||
Total assets | $ | 426,421 | $ | 152,055 | ||||
Liabilities, preferred units and stockholders’ equity/members’ deficit | ||||||||
Current liabilities: | ||||||||
Accounts payable | $ | 1,208 | $ | 418 | ||||
Accrued expenses | 15,970 | 9,562 | ||||||
Total current liabilities | 17,178 | 9,980 | ||||||
Total liabilities | 17,178 | 9,980 | ||||||
Commitments and contingencies | ||||||||
Series A Preferred Units; no units authorized, issued and outstanding at September 30, 2023; 20,000,000 units authorized, issued and outstanding as of December 31, 2022 | – | 28,971 | ||||||
Series B Preferred Units; no units authorized, issued and outstanding at September 30, 2023; 45,089,212 units authorized, issued and outstanding as of December 31, 2022 | – | 148,496 | ||||||
Stockholders’ equity/members’ deficit: | ||||||||
Common Units; no units authorized, issued and outstanding at September 30, 2023; 5,000,000 units authorized, issued and outstanding as of December 31, 2022 | – | 2,251 | ||||||
Incentive Units; no units authorized, issued and outstanding at September 30, 2023; 12,412,473 units authorized, 9,648,374 issued and 1,625,086 outstanding as of December 31, 2022 | – | 2,142 | ||||||
Preferred Stock; 10,000,000 authorized, $0.00001 par value, no shares issued and outstanding September 30, 2023; No shares authorized, issued and outstanding at December 31, 2022 | – | – | ||||||
Common Stock; 400,000,000 authorized, $0.00001 par value, 50,674,296 issued and 48,017,621 outstanding as of September 30, 2023; No shares authorized, issued and outstanding at December 31, 2022 | – | – | ||||||
Additional paid-in capital | 501,143 | – | ||||||
Accumulated other comprehensive income | 135 | – | ||||||
Accumulated deficit | (92,035 | ) | (39,785 | ) | ||||
Total stockholders’ equity/members’ deficit | 409,243 | (35,392 | ) | |||||
Total liabilities, preferred units and stockholders’ equity/members’ deficit | $ | 426,421 | $ | 152,055 |
APOGEE THERAPEUTICS, INC.
CONDENSED CONSOLIDATED STATEMENT OF OPERATIONS |
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THREE MONTHS ENDED SEPTEMBER 30, |
NINE MONTHS ENDED SEPTEMBER 30, |
PERIOD FROM FEBRUARY 4, 2022 (INCEPTION) TO |
||||||||||||||
2023 |
2022 |
2023 |
SEPTEMBER 30, 2022 | |||||||||||||
Operating expenses: | ||||||||||||||||
Research and development | $ | 17,069 | $ | 9,885 | $ | 39,470 | $ | 15,578 | ||||||||
General and administrative | 7,236 | 622 | 16,378 | 1,050 | ||||||||||||
Total operating expenses | 24,305 | 10,507 | 55,848 | 16,628 | ||||||||||||
Loss from operations | (24,305 | ) | (10,507 | ) | (55,848 | ) | (16,628 | ) | ||||||||
Other income (expense), net: | ||||||||||||||||
Interest income | 3,465 | — | 3,598 | — | ||||||||||||
Other financing expense | — | (9,150 | ) | — | (9,150 | ) | ||||||||||
Total other income (expense), net | 3,465 | (9,150 | ) | 3,598 | (9,150 | ) | ||||||||||
Net loss | $ | (20,840 | ) | $ | (19,657 | ) | $ | (52,250 | ) | $ | (25,778 | ) | ||||
Investor Contact:
Noel Kurdi
VP, Investor Relations
Apogee Therapeutics
Noel.kurdi@apogeetherapeutics.com
Media Contact:
Dan Budwick
1AB Media
dan@1abmedia.com
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