PolyPid Ltd. Q1 FY2026 earnings call

Regulatory Progress

• Initiated rolling New Drug Application (NDA) submission for DPLEX-100 (lead candidate for preventing surgical site infections in abdominal colorectal surgery) to the FDA on March 30, 2026, submitting CMC, non-clinical, and administrative modules. Remaining components including the full clinical module are expected imminently to complete the submission.
• Secured a $4.3 million PDUFA fee small business waiver from the FDA, freeing resources for commercial preparation.
• Scheduled alignment meetings with European Medicines Agency (EMA) regulatory bodies to finalize content for the planned Marketing Authorization Application (MAA), which will be submitted via the EMA's centralized procedure. MAA submission is planned for Q3 2026 pending meeting outcomes.

Commercial Development and Readiness

• U.S. strategic commercial partnership discussions have advanced to late stages, with due diligence complete and negotiations of definitive agreement terms now underway. The company's top priority is securing a partner with established hospital presence and sales force capabilities to launch DPLEX-100 in Q1 2027.
• Completed multiple mock FDA inspections, with ongoing pre-approval inspection preparation supported by experienced external industry quality consultants. The company's in-house manufacturing facility has passed four consecutive successful GMP inspections, including the most recent by the Israeli Ministry of Health, positioning it well for FDA inspection.
• Presented new positive clinical data in Q1 2026: a 64% relative risk reduction in clinically significant severe wound infections at the Surgical Infection Society annual meeting, and new pharmacokinetic data confirming 30 days of sustained doxycycline release at ESCMID, which supports the product's core mechanism of action.

Pipeline Strategy

• Post-partnership, the company plans to advance a multi-product pipeline: expanding DPLEX-100 indications beyond abdominal colorectal surgery, expanding the Plex drug delivery platform to other new indications, and advancing an early-stage metabolic health program.

Financial Position

• Fully repaid all outstanding debt in early May 2026 following quarter end, strengthening the balance sheet ahead of potential commercialization.

PolyPID is a clinical-stage biotech company focused on a single lead product candidate (DPLEX-100), so it does not report multiple product segments. All revenue-generating activity has not yet commenced, as the company is still in the regulatory submission phase ahead of potential commercial launch. The company only reports aggregated operating and financial performance for the entire firm: Q1 2026 research and development expenses were $5.8 million (down from $6.1 million in Q1 2025); general and administrative expenses were $1.6 million (up from $1.2 million in Q1 2025); marketing and business development expenses were $0.4 million (up from $0.3 million in Q1 2025); net loss for Q1 2026 was $7.7 million, or $0.35 per share, compared to a net loss of $8.3 million, or $0.70 per share, in Q1 2025. As of March 31, 2026, the company held $10.9 million in cash, cash equivalents, and short-term deposits.

• Full completion of the rolling NDA submission to the FDA is expected imminently.
• DPLEX-100 is eligible for priority review (6-month review timeline vs. the standard 10 months) due to its Fast Track and Breakthrough Therapy Designation, if the FDA accepts the submission.
• MAA submission to the EMA is planned for Q3 2026, pending outcomes of regulatory alignment meetings.
• A U.S. commercial launch of DPLEX-100 via a strategic partner is targeted for Q1 2027.
• Management expects current cash resources are sufficient to fund operations into the second half of 2026 and through all upcoming key regulatory and partnership milestones.
• 2026 is expected to be a transformative year for the company as it transitions from late-stage clinical development to potential commercialization.
• Only modest general and administrative spending increases are expected post-partnership, with larger expense increases concentrated in operational commercial activities.

• All forward-looking statements regarding regulatory approval, partnership completion, launch timing, and funding sufficiency are subject to inherent uncertainties, including risks beyond the company's control that are detailed in the company's SEC filings.
• The ongoing Middle East conflict has disrupted FDA in-person inspection plans for Israeli facilities (FDA did not conduct inspections in Israel after March 2026), though management does not expect a material impact on approval timelines as alternative inspection protocols were developed during the COVID-19 pandemic.
• FDA pre-approval inspection of the company's manufacturing facility could result in major findings that delay or prevent approval, though management has prepared extensively and has not identified any major issues to date.
• Finalization of a strategic commercial partnership is not guaranteed, as negotiations are still ongoing.

Q: Chase Knickerbocker (Craig Hallam) asked two questions: what work was done to prepare the novel CMC module of the DPLEX-100 NDA with confidence, and how have mock FDA inspections progressed and what do findings indicate for inspection readiness?

A: Management explained that the company leveraged breakthrough therapy designation to communicate extensively with the FDA ahead of submission to align on processes and resolve potential concerns early, in addition to working with experienced internal and consultant CMC experts. For inspections, the company owns and controls its manufacturing facility (no reliance on a CMO), has built all processes to meet FDA expectations from day one, and works with veteran FDA quality consultants. All issues identified in mock inspections are minor and either resolved or in process of correction, with no major issues identified.

Q: Jason Butler (Citizens JMP) asked if partnership priorities have shifted during late-stage discussions, and whether the FDA has sent any formal questions or information requests since the initial NDA modules were submitted.

A: Management confirmed partnership priorities have not changed: the company remains focused on securing a partner with strong U.S. hospital presence and established sales force capabilities. No formal FDA requests have been received to date, which is expected because the full NDA submission has not yet been completed. Formal feedback is expected immediately after full submission is complete.

Q: Pasha Yapin (Roth Capital Partners) asked what impact the ongoing Middle East conflict has had on FDA inspection timelines for the company's Israeli manufacturing facility, and whether the company will need to hire additional internal staff to track commercial progress post-partnership, and what that will mean for G&A spending.

A: Management noted the FDA paused in-person inspections in Israel after March 2026, but does not expect any material impact to timelines: the FDA developed alternative inspection pathways during COVID-19, and the company continues to operate on schedule. Some modest increase in headcount and G&A spending is expected, with larger increases concentrated in operational commercial activities rather than general and administrative costs.

Q: Brandon Foulkes (HC Wainwright) asked what pipeline strategy the company will pursue after executing a commercial partnership for DPLEX-100, and whether PolyPID will conduct its own pre-launch market awareness activities this year.

A: Management plans to pursue a broad multi-stage pipeline post-partnership: expanding DPLEX-100 to additional surgery indications, expanding the Plex platform to other indications, and advancing an early-stage metabolic health program. PolyPID will continue to lead all pre-launch scientific and clinical awareness activities (including scientific conferences and publication of SHIELD2 trial data) this year, and will not handle full commercial marketing on its own.