Nektar Therapeutics запускает фазу 3 клинических испытаний препарата Rezpeg для лечения атопического дерматита и очаговой алопеции

On August 13, Nektar Therapeutics (NASDAQ:NKTR) held its second-quarter earnings call and laid out where its lead drug candidate stands after years of development. Rezpegaldesleukin, known as rezpeg, is now enrolling patients in Phase 3 trials for two separate autoimmune conditions, atopic dermatitis and alopecia areata. Management framed the quarter around two numbers that matter most to investors right now: a $1.02 billion cash balance that provides a runway into 2028, and a drug program that finally has late-stage data on the calendar. Betting Big On Two Diseases Nektar's Phase 3 program for atopic dermatitis, called ZENITH AD, began randomizing patients in July 2026 across two pivotal studies, each enrolling 510 adolescent and adult patients. A third study in patients who have already tried other treatments is set to start by the end of September 2026. Management expects top-line data from the first studies in mid-2028, with a Biologics License Application submission to follow in 2029 if results hold up. After an end-of-Phase 2 meeting with the FDA, Nektar also finalized a single registrational Phase 3 study for alopecia areata, called ZENITH AA, which will enroll 850 patients and use a SALT score of 20 or less at week 52, meaning 80% or more scalp hair coverage, as its primary endpoint. The case for rezpeg goes beyond trial design. CEO Howard Robin noted that roughly 15 million people in the U.S. have moderate to severe atopic dermatitis, and fewer than 10% currently get a systemic therapy, leaving room for the market itself to grow. He also pointed out that about half of patients on IL-13 drugs such as Dupixent either stop responding or never respond at all. In alopecia areata, where JAK inhibitors carry boxed warnings that keep many dermatologists away, the market for approved treatments is still projected to reach $5 billion by 2033. Nektar's own market research found that 150 of 151 physicians surveyed preferred rezpeg's short-lived injection site reactions over the longer-lasting conjunctivitis tied to current options, a result management used to argue rezpeg could compete across first, second, and third-line patients. The Losses Keep Piling Up None of this comes cheap. Nektar's operating loss widened to $42.3 million in the second quarter, up from $36.2 million a year earlier, and the net loss came in at $40.6 million, or $1.23 per share. Research and development spending is set to climb further, with full-year guidance now at $210 million to $230 million as the Phase 3 programs and manufacturing activities ramp up. The company's only revenue right now is $10.1 million in noncash royalty income, down from $11.2 million a year ago, and full-year revenue guidance tops out at $45 million. That gap between spending and revenue is why Nektar leaned on a public stock offering that raised $373.8 million in gross proceeds in April 2026, a move that keeps the lights on but also dilutes existing shareholders.