PYPD

Transformative Q2 2026 Milestones

• The FDA accepted PolyPid's new drug application (NDA) for DPLEX-100 (for prevention of surgical site infection (SSI) in abdominal colorectal surgery) for filing with no identified filing issues, ahead of the company's internal timeline.
• The FDA granted DPLEX-100 priority review, shortening the review period to 6 months and setting a Prescription Drug User Fee Act (PDUFA) goal date of November 28, 2026.
• PolyPid signed an exclusive commercialization partnership with Azurity Pharmaceuticals for DPLEX-100 in the United States and Canada in July 2026, following a competitive bidding process.

Partnership Structure and Economics

• PolyPid has already received $30 million in aggregate upfront and near-term milestone payments, and is eligible for over $290 million in additional regulatory, launch, and sales-based milestones.
• The company is entitled to tiered royalties on Azurity sales ranging from mid-teens to mid-twenties percent, and retains global manufacturing rights, earning an agreed transfer price on every unit supplied to Azurity, capturing additional end-product economic value compared to standard licensing deals.
• Azurity will fund a joint development program for DPLEX-100 label expansion into additional SSI indications, requiring no incremental capital from PolyPid.

Regulatory and Commercial Preparation

• The company's Israeli manufacturing facility has passed four consecutive successful GMP inspections, and passed on-site due diligence from Azurity and other bidding partners, validating manufacturing readiness. Multiple mock pre-approval inspections have been completed with external consultants in preparation for the FDA inspection.
• Productive pre-submission meetings were held with EMA lead assessors, and the company remains on track to submit a Marketing Authorization Application (MAA) via the EMA centralized procedure in Q3 2026.
• Joint launch preparation work with Azurity is already underway, with aligned cross-functional working groups covering medical, regulatory, and commercial activities. Azurity leads on commercial execution (Salesforce build-out, account planning, medical affairs, contracting), while PolyPid retains responsibility for global manufacturing and regulatory strategy.

Pipeline and Long-Term Growth Drivers

• Near-term growth drivers include DPLEX-100 label expansion into high-unmet-need additional SSI indications (including C-section, joint replacement, cardiac surgery, and breast surgery), expansion of DPLEX-100 to geographic markets outside the U.S. and Canada, and further development of the company's fully owned Kinatrix long-acting drug delivery platform.
• The company is exploring new treatment indications beyond SSI prevention for the Kinatrix platform, leveraging existing clinical, manufacturing, and safety infrastructure from DPLEX-100 development to compress development timelines for new candidates.

• Management maintains that the PDUFA goal date for the DPLEX-100 NDA is November 28, 2026, with an expected commercial launch of DPLEX-100 by Azurity in the U.S. in early 2027. The earlier-than-anticipated priority review PDUFA date does not change the expected launch timeline, as the company prepared for both accelerated and standard review scenarios.
• The company confirms it remains on track to submit the DPLEX-100 MAA to the EMA in Q3 2026.
• Based on current operating plans and the newly closed Azurity partnership, management expects existing cash resources (including the $30 million in recently received partnership payments) will be sufficient to fund operations into 2028 and through all upcoming key milestones, with no immediate near-term financing needs.

PolyPid is a clinical-stage biopharmaceutical company with only one product candidate, DPLEX-100, that has not yet been commercialized as of Q2 2026. No commercial product revenue was generated in the quarter. Operating expense performance (absolute figures): Research and development (R&D) expenses were $6.1 million in Q2 2026, compared to $6.2 million in Q2 2025. General and administrative (G&A) expenses were $1.3 million in Q2 2026, compared to $2.5 million in Q2 2025. Marketing and business development expenses were $0.5 million in Q2 2026, compared to $0.7 million in Q2 2025. Net loss was $7.8 million ($0.35 per share) in Q2 2026, compared to a net loss of $10 million ($0.78 per share) in Q2 2025. For the first six months of 2026, net loss totaled $15.6 million, compared to $18.2 million in the first half of 2025. As of June 30, 2026, the company held $6.6 million in cash and cash equivalents, with an additional $30 million in upfront and near-term milestone payments from Azurity Pharmaceuticals received subsequent to quarter end, strengthening the total cash position.

• All forward-looking statements regarding regulatory approval, launch timing, milestone achievement, and funding sufficiency are subject to inherent risks and uncertainties, including unexpected regulatory feedback, delays to pre-approval inspection or NDA/MAA review, and failure to obtain marketing approval for DPLEX-100.
• Risks include failure of the FDA pre-approval inspection of the company's manufacturing facility, which could delay or prevent approval even after a successful NDA filing.
• There is no guarantee that DPLEX-100 will achieve successful commercial adoption after launch, or that expected reimbursement (including NTAP coding) will be secured on the expected timeline.
• Pipeline expansion and label expansion development carry inherent risk of unexpected clinical trial failures or regulatory setbacks, even with existing platform infrastructure.

Q: What communication has the FDA had about pre-approval inspection timing, and how did Azurity assess the CMC/manufacturing process during due diligence?

A: The company has had ongoing productive communication with the FDA about inspection requirements as part of the priority review process, but does not disclose specific timing details. Azurity completed full on-site due diligence of the Israeli manufacturing facility alongside other competing potential partners, providing external validation of the company's commercial-scale manufacturing readiness, alongside prior regulatory inspections and internal mock inspections.

Q: How much existing sales coverage does Azurity have for the target colorectal surgeon call points, and how many representatives will detail DPLEX-100 at launch?

A: Azurity already calls on all target colorectal surgeons via its existing hospital-focused sales infrastructure, which currently covers over 1,700 U.S. hospitals and academic medical centers. The company cannot break out specific rep allocation, but Azurity is actively expanding its market access, contracting, and medical capabilities ahead of the launch, with a stepwise rollout planned across hospital systems.

Q: What launch preparation work is Azurity already conducting, and how quickly can label expansion trials start for additional indications?

A: Azurity began pre-launch planning well before deal close, and has already received all pre-existing market research, KOL network, and pricing work from PolyPid. Azurity is already executing pre-approval activities including attendance at key surgical and infectious disease conferences, building the KOL network, and pursuing NTAP reimbursement approval, with all core commercial and contracting teams in place. The top priority label expansion indications (CABG, orthopedic hip/knee, breast mastectomy) have been aligned between the parties, with work set to begin after confirmation of the initial approved indication from the FDA, with all development costs funded by Azurity.

Q: What are the key internal KPIs for tracking launch success, and when will revenue be recognized after launch?

A: The core initial KPIs are the number of hospitals that add DPLEX-100 to their formularies via P&T committee approval, progress on reimbursement with payers (including NTAP), and physician adoption and usage levels during the first 12 months post-launch. Revenue from transfer pricing for manufactured units supplied to Azurity will be recognized immediately upon sale after launch, with milestone and royalty revenue recognized as those triggering events occur.

Q: Does the earlier November 2026 PDUFA date change the early 2027 launch plan, and what is the status of NTAP submission?

A: The company prepared for both accelerated and standard PDUFA timelines, so the earlier date does not change the planned early 2027 launch timeline. NTAP submission does not require FDA approval, only that the product is under FDA review, so Azurity is on track to meet the October 2026 deadline for inclusion in the next U.S. governmental fiscal year.