One takeaway from the ongoing biotech IPO drought is that companies should have at least some clinical data to persuade investors to buy in. Apogee Therapeutics has no human data. In fact, the young company doesn’t have much of a history at all. No matter. Apogee is still looking to tap the public markets to fund clinical development of a pipeline of inflammation and immunology (I&I) drugs, including a lead program that could offer dosing advantages over some currently available atopic dermatitis treatments.
In paperwork filed late last week with the Securities and Exchange Commission, Apogee laid out its IPO objectives. The Waltham, Massachusetts-based company has yet to set financial terms for the offering, but IPO research firm Renaissance Capital penciled in a $100 million placeholder figure for the planned stock market debut. Apogee has applied for a Nasdaq listing under the stock symbol “APGE.”
“Our goal is to become a leader in developing novel therapies for I&I indications,” Apogee said in the IPO filing. “Our 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.”
Apogee was founded in early 2022 by Fairmount Funds and Venrock. It formally launched last December as the first company to spin out of Paragon Therapeutics, Fairmount’s engine for discovering new biologic drugs that overcome limitations of currently available therapies. At the time, the companies disclosed no details about Apogee’s programs, other than to broadly describe an immunology and inflammation focus. There’s more information now.
Lead Apogee program APG777 is an antibody designed to target interleukin 13, or IL-13, a signaling protein associated with inflammatory disorders, including atopic dermatitis, the most common subtype of the skin disorder eczema. Biologic drugs that hit this target are already available, the biggest being the blockbuster Regeneron Pharmaceuticals and Sanofi antibody drug Dupixent. In addition to targeting IL-13, this injectable medicine also blocks another pathway called IL-4. LEO Pharma’s Adbry is a newer entry into the market for IL-13-blocking atopic dermatitis drugs, having won its FDA approval in 2021. Meanwhile, Eli Lilly awaits an FDA decision for lebrikizumab, its IL-13 drug for the skin disorder. All of these antibody drugs are administered as injections every other week to every four weeks.
Apogee’s APG777 is designed with an extended half-life, which the company expects will enable the drug to achieve maintenance dosing every two to three months. That projection is based on preclinical research, so the durability of the therapy still needs to be demonstrated in humans.
Apogee has applied for permission to begin Phase 1 testing in Australia. The study is expected to begin enrolling healthy volunteers in the second half of this year and then post preliminary data in the middle of next year, the company said in the filing. If successful, Apogee plans to proceed to Phase 2 testing in atopic dermatitis. It also said that positive Phase 1 results could pave the way for mid-stage tests in other immunology and inflammation indications, including alopecia areata, chronic rhinosinusitis with nasal polyps, chronic spontaneous urticaria, eosinophilic esophagitis, and prurigo nodularis.
The next program in the Apogee pipeline is APG808, a subcutaneously injected antibody designed with an extended half-life. This drug, which targets IL-4R alpha, is a potential treatment for chronic obstructive pulmonary disease. Based on preclinical research, Apogee believes this drug can be dosed every six weeks to every two months as a maintenance therapy.
Apogee has two more preclinical programs licensed from Paragon, one that targets OX40L and another that targets both IL-13 and OX40L. The company plans to develop both antibodies for atopic dermatitis. Since OX40L is upstream in the inflammatory pathway, hitting this target offers the potential to have a broader effect on the inflammatory cascade, the company said in the filing.
Since inception, Apogee has raised $169 million, which breaks down to $20 million at its start and $149 million in a Series B round that was announced concurrent with its launch last December. That round was led by Deep Track Capital and RTW Investments. Those investors, along with Fairmount and Venrock, are among Apogee’s largest shareholders though the size of their equity stakes remain undisclosed.
Apogee is led by CEO Michael Henderson, who was previously the chief business officer of BridgeBio Pharma. Soon after its launch, Apogee appointed Chief Financial Officer Jane Pritchett Henderson (no relation), who brings experience from several public and private biotech companies. Prior to joining Apogee, she was CFO and chief business officer of Invivyd Therapeutics (formerly Adagio Therapeutics), where she led the company’s crossover financing and subsequent IPO in 2021.
Without specifying any dollar amounts, Apogee said in the filing that the IPO proceeds will be used to fund lead program APG777 through Phase 2 testing, pending positive Phase 1 results. Additional unspecified amounts will support development of the other three programs in its pipeline. Apogee reported having $141.3 million in cash at the end of the first quarter of this year, which the company estimated will be enough to finance operations for the next 12 months.
Photo: Angela Weiss/AFP, via Getty Images
