Apogee Therapeutics New 52WH following Q4 and FY 2023 Financial Results and Phase 1 APG777 Trial Update

March 5, 2024

DENVER, Colo., Mar 05, 2024 (247marketnews.com)- Apogee Therapeutics, Inc. (NASDAQ:APGE) reported, this morning, its fourth quarter and full year 2023 financial results, as well as pipeline highlights.

Apogee reported positive, interim Phase 1 results for APG777, which exceeded trial objectives and delivered ahead of schedule, and that it ended 2023 with $395.5 million total cash, with expected cash runway into 4Q 2026.

APGE is trading at $56.70, up $14.96 (+35.84%), on 3M shares. Its 52-week range is now $14.19 to $65.41, after setting a new 52-week high a few minutes after the open.

“2023 was a momentous year for Apogee with the completion of a successful IPO, initiation of our first clinical program of APG777 in healthy volunteers and the nomination of our second pipeline candidate, APG808,” said Michael Henderson, M.D., Chief Executive Officer of Apogee. “Our momentum and track record of execution have continued in 2024, and we were thrilled to disclose positive interim results from our Phase 1 trial of APG777 today, which demonstrated a favorable safety profile and exceeded our trial objectives on both pharmacokinetics and pharmacodynamics. This data readout is a key risk-reducing milestone for our APG777 program and pipeline and supports a path forward into a Phase 2 trial for APG777 in patients with AD in the first half of this year. Looking ahead to the rest of the year, we continue to make progress with APG808, for which we are set to start a Phase 1 healthy volunteer clinical trial ahead of schedule while advancing our earlier programs, APG990 and APG222. With each of our programs, we have the potential to reshape the standard of care with potential best-in-class or first-in-class therapeutic candidates for I&I diseases.”

“The positive PK, PD and safety findings from our Phase 1 trial mark the first clinical data ahead of schedule from our portfolio of potentially differentiated biologics and underscore the promising potential of APG777 to offer patients a transformational therapy that could drive improved clinical responses than the current standard of care and extend dosing to every three or six months,” said Michael Henderson, M.D., Chief Executive Officer of Apogee. “We are excited to embark on the next phase of development for APG777, with plans to initiate our Phase 2 clinical trial in the first half of this year while rapidly progressing the rest of our pipeline forward. At Apogee, we refuse to stop at good enough and are dedicated to advancing innovative solutions for patients. Today’s announcement brings us an important step closer to achieving this goal.”

“Currently approved therapies for atopic dermatitis and other immunology indications typically call for injections every two to four weeks, which can lead to poor treatment adherence and long-term disease control,” said Jonathan Silverberg, MD, PhD, MPH, Professor of Dermatology at The George Washington University School of Medicine and Health Sciences. “I am very encouraged by the initial data from this study, which demonstrate the potential for APG777 as a well-tolerated treatment with a half-life that would support less frequent injections.”

“Significant unmet need remains for patients with moderate-to-severe AD, many of whom continue to have symptomatic disease on current therapies,” said Emma Guttman-Yassky, MD, PhD, the Waldman Professor of Dermatology and Immunology and Health System Chair of Dermatology at the Icahn School of Medicine at Mount Sinai in New York City. “APG777’s Phase 2 trial will test an important hypothesis, greater inhibition of the pathway during induction, to see if improved clinical responses can be delivered for patients living with AD.”

“The interim results from this Phase 1 trial are tremendously encouraging for APG777’s potential to meaningfully improve the standard of care for patients with moderate-to-severe AD. On behalf of the entire Apogee team, I’d like to extend our heartfelt gratitude to the volunteers, investigator, and the study team for their support in the successful execution of this important trial,” said Carl Dambkowski, M.D., Chief Medical Officer of Apogee Therapeutics. “We look forward to rapidly advancing APG777 into Phase 2 clinical trials in AD and other inflammatory conditions.”

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