PolyPid Ltd. Q2 FY2025 earnings call

• The second quarter of 2025 was transformational with the successful SHIELD II Phase III trial showing significant clinical benefits of D-PLEX100 in preventing surgical site infections in abdominal colorectal surgeries, including a 38% reduction in the primary endpoint and 58% reduction in SSI rate. • The GLP-1 program was unveiled, aiming to develop a 60-day no-burst GLP-1 receptor agonist peptide for metabolic diseases. • Appointed Dr. Nurit Tweezer-Zaks as Chief Medical Officer, bringing extensive medical R&D and business development expertise. • Strengthened the balance sheet through a successful warrant exercise inducement transaction, extending cash runway into 2026. • Intensified commercial preparation activities and partnership discussions for D-PLEX100, with the total addressable market in the U.S. estimated at over 12 million surgeries annually.

As of June 30, 2025, PolyPid had cash and cash equivalents of $17.4 million and short-term deposits of $12 million, totaling $29.5 million. For the second quarter of 2025, research and development expenses were $6.2 million, general and administrative expenses were $2.5 million, marketing and business development expenses were $0.7 million, and the net loss was $10 million or $0.78 per share. For the 6 months ended June 30, 2025, research and development expenses were $12.3 million, general and administrative expenses were $3.7 million, marketing and business development expenses were $1 million, and the net loss was $18.2 million or $1.48 per share.

• Anticipate submitting the NDA to the FDA in early 2026 and the marketing authorization application in Europe shortly thereafter. • The GLP-1 program is entering more robust preclinical studies. • Partnership with Advance Pharma has milestones to be assessed, with both parties actively working on finalizing activities related to the partnership.

• Forward-looking statements are subject to numerous risks and uncertainties, including those described in the company's SEC filings, which could cause actual results to materially differ from projections.

Q: On the NDA filing, can you walk through the larger items left to be done between now and 1Q?

A: We are in the finalization stages of the CMC and clinical module. We will submit a pre-NDA meeting request in the next few weeks, expect a pre-NDA meeting by the end of 2025, and submit the NDA in early 2026.

Q: Talk about path forward for GLP-1 program and Advance partnership milestones?

A: The GLP-1 program is going into more robust preclinical studies. Regarding the Advance partnership, there are milestones to be assessed with both parties working on finalizing activities.

Q: Regarding Dr. Tweezer-Zaks joining and balance sheet bolstering?

A: Dr. Tweezer-Zaks brings extensive medical R&D and business development expertise. Bolstering the balance sheet will be through partner financing and expected payments from partners.