Apogee Therapeutics (NASDAQ:APGE) executives said the company is preparing to move its lead drug candidate, zumilokibart, into Phase 3 testing later this year after reporting Phase 2b data in atopic dermatitis and securing a major financing agreement with Blackstone.
Speaking at a Jefferies-hosted event, Michael Henderson, chief executive officer of Apogee Therapeutics, said zumilokibart, or Zumi, is being developed for Type 2 inflammatory diseases, with atopic dermatitis as the lead indication. Henderson said the company’s recently released Phase 2b data showed “very competitive efficacy” with four dosing days during induction. He also said data released earlier this year showed that dosing every three to six months after induction could maintain efficacy and lead to improved responses over time.
Blackstone Financing Removes Near-Term Funding Overhang, Executives Say
Apogee executives highlighted the company’s $1.3 billion financing collaboration with Blackstone as a key part of its strategy entering Phase 3. Henderson said the agreement, combined with the company’s existing balance sheet, gives Apogee cash “through launch and even commercialization and profitability.” He said the company now enters Phase 3 “without a financing overhang.”
Jane Pritchett Henderson, Apogee’s chief financial officer, said the Blackstone transaction was the “largest pre-Phase 3 deal” of its type and reflected Blackstone’s conviction in Zumi. She said Apogee focused on three priorities in negotiations: the amount of capital available, the cost of capital and strategic optionality.
Pritchett Henderson said the capital available under the deal means Apogee has “no need for equity.” She added that Apogee negotiated royalty rates that decline with sales, flexibility around how much capital to draw down and a potential future option to buy down the royalty to a “very low single-digit royalty rate,” if appropriate. She also said the agreement does not include “onerous governance features.”
Asked about whether the financing affects strategic optionality, Michael Henderson said companies want to be in “a position of strength, not weakness” in any strategic discussion. He said Apogee now has a clear independent path to launch Zumi if that is the best route, while also noting that another company with a lower cost of capital could potentially accelerate combination development or indication expansion.
Company Positions Zumi as a Frontline Atopic Dermatitis Therapy
Jeff Hartness, Apogee’s chief commercial officer, said Zumi is being positioned as a first-line biologic option in atopic dermatitis after topical therapies. He compared the potential commercial setup to the launch of Skyrizi in plaque psoriasis, saying that product gained broad uptake despite launching into a competitive market because it offered an extended dosing option.
Hartness said dosing frequency and patient persistence are important for patients, physicians and payers. He said Dupixent has about a 73% persistence rate in the first year and that roughly half of patients discontinue by the end of the second year. By comparison, he said Skyrizi in plaque psoriasis has a first-year persistence rate of about 95%.
Hartness said higher persistence can reduce office visits, use of additional therapies and switching. He said switching matters to payers because patients often restart induction dosing on a new product, which is more costly. He argued that Zumi’s dosing profile — four dosing days during induction and two to four dosing days per year in maintenance — could make it appealing as an initial biologic choice in atopic dermatitis.
Development Strategy Includes Dose Finding in New Therapeutic Areas
Carl Dambkowski, Apogee’s chief medical officer, said the company is taking a deliberate approach to dose optimization as it expands Zumi into additional indications. He said Apogee wants to balance speed with ensuring that it selects the right dose to maximize efficacy.
Dambkowski said Apogee’s atopic dermatitis work showed the value of dose optimization, saying the company could have either selected a less convenient dose with a higher injection burden or underdosed the drug and missed additional efficacy. He cited the company’s top-line atopic dermatitis data, including 65% EASI 75, more than 40% placebo-adjusted EASI 75, and mid-40% rates for both EASI 90 and IGA 0/1, with placebo-adjusted results in the mid-30% range.
For dermatology indications, Dambkowski said the company now believes it has an optimized dose that could support expansion into other dermatologic diseases without repeating dose-ranging studies. He listed prurigo nodularis, bullous pemphigoid and chronic spontaneous urticaria as examples of potential dermatology opportunities.
In respiratory disease, however, Dambkowski said Apogee plans to conduct dose-ranging work in asthma before moving into additional respiratory indications such as COPD, allergic rhinitis or chronic rhinosinusitis with nasal polyps. He said regulators historically want dose-ranging data within a therapeutic area because endpoints and disease trajectories vary.
Respiratory Combination Plans Expected Later This Year
Dambkowski said Apogee expects to announce plans later this year for a combination involving Zumi and APG333, the company’s extended half-life TSLP program. He said timing for the start of that combination work could fall in 2027 or 2028, but more details are expected later.
For Zumi monotherapy in asthma and potentially COPD, Dambkowski said Apogee expects to focus on a Type 2-enriched population, using eosinophils above 150 as a marker. He said the potential Zumi-plus-APG333 combination could be aimed at a broader population, including patients with eosinophils below 150, where he said unmet need remains high.
Pritchett Henderson said a global Phase 2 trial could cost about $250,000 per patient. She said a combination trial could be larger than a monotherapy study, potentially up to 50% larger, with more details to come when the company discloses plans for the combination in the second half of the year.
APG279 Bar Depends on Zumi’s Atopic Dermatitis Performance
Henderson also discussed APG279, Apogee’s IL-13 and OX40 ligand fixed-dose combination. He said the program is being tested head-to-head against Dupixent in an approximately 86-patient randomized trial.
Henderson said the better Zumi performs in atopic dermatitis, the higher the internal bar becomes for advancing APG279. He said physicians have indicated they would want to see about a 10-point delta, which he said implies a 15- to 20-point delta versus Dupixent in the current study for Apogee to justify allocating more capital.
If APG279 meets that bar, Henderson said it could show “profound efficacy” and potentially become a second-line option in atopic dermatitis, where he said JAK inhibitors are currently the main option. He said Apogee will know if the trial does not meet that threshold.
Henderson said Apogee’s top priorities remain Zumi approval in atopic dermatitis, followed by expansions into other indications. He said the company has invested in people, manufacturing and clinical research organization relationships ahead of key milestones, and that separate teams are focused on atopic dermatitis, asthma and eosinophilic esophagitis.
About Apogee Therapeutics (NASDAQ:APGE)
Apogee Therapeutics, Inc is a clinical-stage biotechnology company dedicated to the discovery and development of novel small molecule therapeutics that selectively target the nuclear receptor RORγt, a master regulator of T cell-driven inflammatory pathways. By modulating RORγt activity, Apogee aims to offer an oral treatment option for patients with autoimmune and inflammatory skin disorders.
The company’s lead candidate, APG-157, is an oral RORγt inverse agonist currently undergoing early-stage clinical evaluation for moderate to severe plaque psoriasis.
