PolyPid Q4 Earnings Call Highlights

1 month ago 19

MarketBeat

Wed, February 11, 2026 astatine 8:52 AM CST 7 min read

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FDA-backed rolling NDA way for D-PLEX100: PolyPid received affirmative FDA feedback supporting a rolling NDA submission for D-PLEX100 with plans to statesman by extremity of Q1 2026, targeting an archetypal statement for prevention of surgical tract infections successful abdominal colorectal country and expecting a ~six-month precedence review.
U.S. commercialized readiness and concern talks are advancing: Management is successful elaborate discussions with hospital-focused partners and is gathering pre-launch activities (KOL engagement, publications, pricing and health-economics work), with a European submission expected astir 1 4th aft the FDA filing.
Limited currency runway into 2H 2026: As of Dec. 31, 2025 PolyPid had $12.9M successful currency positive $3.7M successful post-period warrant proceeds, reported a Q4 nett nonaccomplishment of $8.5M and a full-year 2025 nett nonaccomplishment of $34.2M, and expects existing resources to money operations into the 2nd fractional of 2026.
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PolyPid (NASDAQ:PYPD) said 2025 marked a “pivotal year” arsenic the institution completed its SHIELD II Phase 3 proceedings and moved D-PLEX100 into the last stages of regulatory preparation, portion besides advancing U.S. commercialized concern discussions up of a planned caller cause exertion submission successful aboriginal 2026.

Chief Executive Officer Dikla Czaczkes Akselbrad said the institution precocious received affirmative written feedback from the U.S. Food and Drug Administration pursuing pre-NDA gathering communications. According to management, the FDA supported PolyPid’s program to prosecute a rolling NDA reappraisal for D-PLEX100, and the institution expects to statesman the rolling submission by the extremity of the archetypal 4th of 2026.

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PolyPid besides said the FDA agreed that the existing objective information package, including results from the SHIELD II Phase 3 trial, “appears adequate” to enactment NDA submission and review. Management described that feedback arsenic providing clarity connected submission operation and expectations.

During the Q&A, Akselbrad said PolyPid is targeting an archetypal statement focused connected prevention of surgical tract infections successful patients undergoing abdominal colorectal surgery, noting that this denotation is straight supported by SHIELD II information and aligns with D-PLEX100’s breakthrough therapy designation. She added that the institution expects determination “may beryllium an opportunity” to measure imaginable statement enlargement into broader abdominal surgical applications during the reappraisal process and said PolyPid plans to conscionable with the FDA to sermon broader statement considerations arsenic portion of its readying timeframe.