$345 million in gross proceeds raised in upsized IPO, providing a projected operating runway into 4Q 2026
Phase 1 clinical trial initiated and first participant dosed ahead of schedule for lead product candidate, APG777, a fully optimized and half-life extended anti-IL-13 antibody for the treatment of atopic dermatitis
Leadership further strengthened with appointments of industry leaders to its board of directors and executive team
SAN FRANCISCO and WALTHAM, Mass., Aug. 28, 2023 (GLOBE NEWSWIRE) — Apogee Therapeutics, Inc. (Nasdaq: APGE), a clinical-stage biotechnology company advancing differentiated biologics for the treatment of atopic dermatitis (AD), chronic obstructive pulmonary disease (COPD) and other inflammatory and immunology (I&I) indications, today provided a review of its pipeline of potentially best-in-class monoclonal antibody (mAb) therapies for I&I diseases, along with key anticipated milestones and recent business progress. In addition, Apogee reported second quarter 2023 financial results and provided guidance on its projected operating runway.
“We have achieved remarkable growth and progress across all aspects of Apogee’s business in 2023 to date, marked by the important milestones of transitioning to both a publicly traded and clinical-stage company,” said Michael Henderson, M.D., Chief Executive Officer of Apogee. “In the last year we have made noteworthy progress in our mission to develop therapeutic options for patients by advancing novel, potentially best in class antibodies that we believe may significantly improve upon standard of care. Our broad pipeline has the potential to overcome limitations of existing therapies for AD, asthma and COPD. And we have capitalized the company with an upsized IPO consisting of new and existing top tier investors that provides sufficient funding to support our operations through multiple clinical catalysts for our lead programs. We have attracted an incredibly talented and passionate team of industry leaders and experts across our board of directors, R&D and business operations. This is an exciting time for Apogee, and we are confident in our ability to deliver value from our potentially best-in-class therapeutic candidates to benefit patients living with I&I diseases.”
Pipeline Highlights and Upcoming Milestones
Recent Corporate Highlights
Second 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), 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 properties, including half-life extension. 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. For more information, please visit www.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, 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, APG990, APG222, and any other potential programs, potential additional indications for APG777, the anticipated timing for selection of development candidates and our other 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 Registration Statement on Form S-1, as amended, declared effective by the SEC on July 13, 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, LLC | ||||||||
CONDENSED CONSOLIDATED BALANCE SHEETS | ||||||||
(UNAUDITED) | ||||||||
(In thousands) | ||||||||
JUNE 30, 2023 |
DECEMBER 31, 2022 |
|||||||
Assets | ||||||||
Current assets: | ||||||||
Cash | $ | 125,069 | $ | 151,890 | ||||
Prepaid expenses and other current assets | 5,598 | 165 | ||||||
Total current assets | 130,667 | 152,055 | ||||||
Total assets | $ | 130,667 | $ | 152,055 | ||||
Liabilities, preferred units and members’ deficit | ||||||||
Current liabilities: | ||||||||
Accounts payable | $ | 11,148 | $ | 418 | ||||
Accrued expenses | 6,467 | 9,562 | ||||||
Total current liabilities | 17,615 | 9,980 | ||||||
Total liabilities | 17,615 | 9,980 | ||||||
Commitments and contingencies | ||||||||
Series A Preferred Units; 20,000,000 units authorized, issued and outstanding as of June 30, 2023 and December 31, 2022; liquidation of $20,000 value as of June 30, 2023 and December 31, 2022 | 28,971 | 28,971 | ||||||
Series B Preferred Units; 45,089,212 units authorized, issued and outstanding as of June 30, 2023 and December 31, 2022; liquidation of $149,000 value as of June 30, 2023 and December 31, 2022 | 148,496 | 148,496 | ||||||
Members’ deficit: | ||||||||
Common Units; 5,000,000 units authorized, issued and outstanding as June 30, 2023 and December 31, 2022 | 2,251 | 2,251 | ||||||
Incentive Units; 16,537,557 units authorized, 14,270,275 issued and 2,481,543 outstanding as of June 30, 2023; 12,412,473 units authorized, 9,648,374 issued and 1,625,086 outstanding as of December 31, 2022 | 4,529 | 2,142 | ||||||
Accumulated deficit | (71,195 | ) | (39,785 | ) | ||||
Total members’ deficit | (64,415 | ) | (35,392 | ) | ||||
Total liabilities, preferred units and members’ deficit | $ | 130,667 | $ | 152,055 |
APOGEE THERAPEUTICS, LLC | ||||||||||||||||
CONDENSED CONSOLIDATED STATEMENT OF OPERATIONS AND COMPREHENSIVE LOSS | ||||||||||||||||
(UNAUDITED) | ||||||||||||||||
(In thousands) | ||||||||||||||||
THREE MONTHS ENDED JUNE 30, |
SIX MONTHS ENDED JUNE 30, |
PERIOD FROM FEBRUARY 4, 2022 (INCEPTION) TO JUNE 30, |
||||||||||||||
2023 | 2022 | 2023 | 2022 | |||||||||||||
Operating expenses: | ||||||||||||||||
Research and development | $ | 13,946 | $ | 1,448 | $ | 22,401 | $ | 5,693 | ||||||||
General and administrative | 4,939 | 368 | 9,142 | 428 | ||||||||||||
Total operating expenses | 18,885 | 1,816 | 31,543 | 6,121 | ||||||||||||
Loss from operations | (18,885 | ) | (1,816 | ) | (31,543 | ) | (6,121 | ) | ||||||||
Other income (expense), net: | ||||||||||||||||
Interest income | — | — | 133 | — | ||||||||||||
Total other income (expense), net | — | — | 133 | — | ||||||||||||
Net loss and comprehensive loss | $ | (18,885 | ) | $ | (1,816 | ) | $ | (31,410 | ) | $ | (6,121 | ) | ||||
Investor Contacts:
Noel Kurdi
VP, Investor Relations
Apogee Therapeutics
Noel.kurdi@apogeetherapeutics.com
Alex Straus
THRUST Strategic Communications
alex@thrustsc.com
Media Contact:
Dan Budwick
1AB Media
dan@1abmedia.com
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