One takeaway from the continuing biotech IPO drought is that corporations ought to have not less than some scientific information to steer buyers to purchase in. Apogee Therapeutics has no human information. The truth is, the younger firm doesn’t have a lot of a historical past in any respect. Regardless of. Apogee remains to be seeking to faucet the general public markets to fund scientific growth of a pipeline of irritation and immunology (I&I) medicine, together with a lead program that would provide dosing benefits over some at the moment obtainable atopic dermatitis remedies.
In paperwork filed late final week with the Securities and Change Fee, Apogee laid out its IPO targets. The Waltham, Massachusetts-based firm has but to set monetary phrases for the providing, however IPO analysis agency Renaissance Capital penciled in a $100 million placeholder determine for the deliberate inventory market debut. Apogee has utilized for a Nasdaq itemizing beneath the inventory image “APGE.”
“Our purpose is to turn out to be a frontrunner in growing novel therapies for I&I indications,” Apogee mentioned within the IPO submitting. “Our antibody applications are designed to beat limitations of present therapies by focusing on well-established mechanisms of motion and incorporating superior antibody engineering to optimize half-life and different properties.”
Apogee was based in early 2022 by Fairmount Funds and Venrock. It formally launched final December as the primary firm to spin out of Paragon Therapeutics, Fairmount’s engine for locating new biologic medicine that overcome limitations of at the moment obtainable therapies. On the time, the businesses disclosed no particulars about Apogee’s applications, aside from to broadly describe an immunology and irritation focus. There’s extra data now.
Lead Apogee program APG777 is an antibody designed to focus on interleukin 13, or IL-13, a signaling protein related to inflammatory issues, together with atopic dermatitis, the most typical subtype of the pores and skin dysfunction eczema. Biologic medicine that hit this goal are already obtainable, the most important being the blockbuster Regeneron Prescribed drugs and Sanofi antibody drug Dupixent. Along with focusing on IL-13, this injectable medication additionally blocks one other pathway referred to as IL-4. LEO Pharma’s Adbry is a more moderen entry into the marketplace for IL-13-blocking atopic dermatitis medicine, having received its FDA approval in 2021. In the meantime, Eli Lilly awaits an FDA determination for lebrikizumab, its IL-13 drug for the pores and skin dysfunction. All of those antibody medicine are administered as injections each different week to each 4 weeks.
Apogee’s APG777 is designed with an prolonged half-life, which the corporate expects will allow the drug to realize upkeep dosing each two to a few months. That projection is predicated on preclinical analysis, so the sturdiness of the remedy nonetheless must be demonstrated in people.
Apogee has utilized for permission to start Part 1 testing in Australia. The examine is predicted to start enrolling wholesome volunteers within the second half of this yr after which submit preliminary information in the course of subsequent yr, the corporate mentioned within the submitting. If profitable, Apogee plans to proceed to Part 2 testing in atopic dermatitis. It additionally mentioned that constructive Part 1 outcomes might pave the best way for mid-stage checks in different immunology and irritation indications, together with alopecia areata, continual rhinosinusitis with nasal polyps, continual spontaneous urticaria, eosinophilic esophagitis, and prurigo nodularis.
The following program within the Apogee pipeline is APG808, a subcutaneously injected antibody designed with an prolonged half-life. This drug, which targets IL-4R alpha, is a possible remedy for continual obstructive pulmonary illness. Based mostly on preclinical analysis, Apogee believes this drug may be dosed each six weeks to each two months as a upkeep remedy.
Apogee has two extra preclinical applications licensed from Paragon, one which targets OX40L and one other that targets each IL-13 and OX40L. The corporate plans to develop each antibodies for atopic dermatitis. Since OX40L is upstream within the inflammatory pathway, hitting this goal affords the potential to have a broader impact on the inflammatory cascade, the corporate mentioned within the submitting.
Since inception, Apogee has raised $169 million, which breaks all the way down to $20 million at its begin and $149 million in a Collection B spherical that was introduced concurrent with its launch final December. That spherical was led by Deep Observe Capital and RTW Investments. These buyers, together with Fairmount and Venrock, are amongst Apogee’s largest shareholders although the dimensions of their fairness stakes stay undisclosed.
Apogee is led by CEO Michael Henderson, who was beforehand the chief enterprise officer of BridgeBio Pharma. Quickly after its launch, Apogee appointed Chief Monetary Officer Jane Pritchett Henderson (no relation), who brings expertise from a number of private and non-private biotech corporations. Previous to becoming a member of Apogee, she was CFO and chief enterprise officer of Invivyd Therapeutics (previously Adagio Therapeutics), the place she led the corporate’s crossover financing and subsequent IPO in 2021.
With out specifying any greenback quantities, Apogee mentioned within the submitting that the IPO proceeds will probably be used to fund lead program APG777 by way of Part 2 testing, pending constructive Part 1 outcomes. Extra unspecified quantities will assist growth of the opposite three applications in its pipeline. Apogee reported having $141.3 million in money on the finish of the primary quarter of this yr, which the corporate estimated will probably be sufficient to finance operations for the subsequent 12 months.
Photograph: Angela Weiss/AFP, by way of Getty Photographs
