Pictured: Apogee CEO Michael Henderson/courtesy of Apogee Therapeutics
Paragon Therapeutics spinout Apogee Therapeutics has filed for an initial public offering, though the company has yet to reveal how many shares of its common stock it is putting up for sale and at what price, according to an SEC filing posted Thursday.
After the IPO, the San Francisco- and Waltham, MA-based biotech will trade on Nasdaq under the symbol APGE.
According to the SEC document, Apogee has two classes of common stock: non-voting and voting. In the current IPO, the company is specifically offering its voting common stock up for sale. Apogee expects to deliver the shares of common stock this year, though no specific date was given.
As Paragon’s first spinout company, Apogee launched in December 2022 with an oversubscribed $149 million series B funding round and a mission to develop novel biologics for inflammatory and immunological diseases.
At the time, however, not much was known about Apogee. In an interview with BioSpace, Apogee CEO Michael Henderson declined to reveal the exact mechanism of action for its lead asset APG777. Henderson also declined to provide details about what targets they were going after.
In Thursday’s SEC posting, the start-up provided more information regarding its pipeline. APG777 is Apogee’s most mature candidate and is currently awaiting regulatory clearance for clinical studies. The candidate is a subcutaneous extended half-life monoclonal antibody targeting the IL-13 cytokine and is being developed for atopic dermatitis (AD) and asthma.
Apogee is preparing to launch a Phase I study of APG777 in healthy volunteers later this year, with initial pharmacokinetic and safety data in mid-2024. Next, the company is eyeing Phase II trials in AD and asthma and will evaluate the candidate’s potential in other inflammatory and immune diseases.
If all goes well for Apogee, APG777 will enter a therapeutic space dominated by Sanofi’s and Regeneron’s drug Dupixent (dupilumab), which was first approved for moderate-to-severe AD in adult patients in March 2017. The therapeutic antibody has since been authorized for use in adolescent and pediatric patients.
Dupixent is a mega-blockbuster drug and brought in nearly $8.7 billion in total sales in 2022.
Apogee’s second most advanced program is APG808, which is also a subcutaneously administered monoclonal antibody designed to have an extended half-life. APG808 targets IL-4Rα, a cytokine receptor known to play a role in chronic obstructive pulmonary disease. The company expects to nominate a development candidate for the APG808 program within the year and then file an Investigational New Drug application to initiate clinical trials.
Apogee has several other earlier candidates, including APG990 and APG222, which target other mechanisms in the inflammatory cascade. The company is initially developing these molecules for AD and will explore immunological indications.
Tristan Manalac is an independent science writer based in metro Manila, Philippines. He can be reached at tristan@tristanmanalac.com or tristan.manalac@biospace.com.
