PolyPid Ltd. Ordinary Shares 2026 Q2 Earnings Call

Thank you, operator. Thank you all for joining PolyPid's second quarter 2026 earnings conference call. Joining me on the call today will be Dikla Czaczkes Akselbrad, Chief Executive Officer of PolyPid, Jonny Missulawin, PolyPid's Chief Financial Officer, and Ori Warshavsky, Chief Operating Officer, U.S. of PolyPid. Earlier today, PolyPid released its financial results for the three and six months ended June 30, 2026. A copy of the press release is available on the investor section of the company's website at www.polypid.com. I'd like to remind you all that on this call, management will make forward-looking statements within the meaning of the Federal Securities laws. For example, management is making forward-looking statements when it's discussing the company's exclusive commercialization partnership with Azurity Pharmaceuticals for the United States and Canada.

These forward-looking statements include the partnership's economic structure, including the potential milestone payments, tiered royalties, and transfer price, the joint development activities, and label expansion program contemplated under the agreement, the expected timing and progress towards potential U.S. Food and Drug Administration or FDA approval of D-PLEX100, including the assigned Prescription Drug User Fee Act, or PDUFA goal date, and the FDA's grant of priority review. Additional forward-looking statements include the company's engagements with the European Medicines Agency, including meetings with the rapporteur and co-rapporteur regarding the planned marketing authorization application or MAA, and the anticipated timing thereof, the expected commercial launch of D-PLEX100 by Azurity in the United States in early 2027.

Further forward-looking statements include the company's manufacturing readiness and preparation for the FDA pre-approval inspection, the potential clinical and economic value of D-PLEX100, the company's PLEX technology and additional pipeline opportunities, growth drivers, and the expectation that the company's existing cash resources will be sufficient to fund operations into 2028 and through several significant upcoming potential milestones. Forward-looking statements are subject to numerous risks and uncertainties, many of which are beyond the company's control, including the risks described from time to time in the company's Securities and Exchange Commission filings. Accordingly, you should not place undue reliance on these statements. I encourage you to review the company's filings with the SEC, including the company's annual report on Form 20-F, filed on February 25, 2026. PolyPid disclaims any intention or obligation, except as required by law, to update or revise any forward-looking statements.

This conference call contains time-sensitive information and speaks only as of the live broadcast today, August 12, 2026. With that, it is my pleasure to turn the call over to Dikla Czaczkes Akselbrad, the CEO of PolyPid.

Dikla? Thank you, Yehuda, and thank you all for joining us today.

The second quarter of 2026 was a defining quarter for PolyPid. During and shortly after the quarter, we accomplished two transformative milestones that together fundamentally reshaped the profile of our company. First, the FDA's acceptance for filing of our new drug application, or NDA, for D-PLEX100 with priority review, and second, the signing of an exclusive commercialization partnership with Azurity Pharmaceuticals for the U.S. and Canada. Starting with regulatory progress. During the second quarter, we completed the NDA submission for D-PLEX100 for the prevention of surgical site infection, or SSIs, in patients undergoing abdominal corrective surgery. Subsequent to quarter end, on July 27, 2026, the FDA formally accepted our NDA for filing.

This acceptance came ahead of our own internal timeline, reflecting what we see as the strength of the underlying submission package and the collaborative interactions we had with the agency during and prior to filing. Importantly, in the acceptance itself, the FDA identified no filing review issues in our submission. We view this as a meaningful positive signal. In parallel with the acceptance, the FDA granted the NDA of D-PLEX100 a priority review. This is a designation the agency reserves for drug candidates that, in its judgment, have the potential to represent a significant improvement in the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions. Practically, priority review shortens the standard review period from 10 months to six months, and it sets a PDUFA goal date to November 28, 2026.

Taken together, an ahead-of-schedule acceptance, no filing review issues, and the grant of priority review represent three outcomes that we believe form a robust starting point to the NDA review process and reflect the strength of the clinical and regulatory foundations we have built with D-PLEX100 over these last several years. Turning to our commercial partnership. On July 17, 2026, we entered into an exclusive commercialization agreement with Azurity Pharmaceuticals for D-PLEX100 in the U.S. and Canada. We are very pleased with this partnership. The selection of Azurity reflects not only its proven commercial capabilities, but also its reputation as a long-term strategic partner capable of unlocking the full value of differentiated specialty pharmaceutical assets. Ori will provide some color in a moment on why we are so excited about having Azurity as our commercial partner, including the competitive business development process behind our selection.

At a high level, we view the economic structure of this partnership as exceptionally strong for a commercialization deal at this stage. We already secured a total of $30 million in upfront and near-term milestone payments. In addition, we are eligible to receive over $290 million in additional regulatory launch and sales milestones. I want to be clear that these milestones are structured around specific corporate, regulatory, and commercial events that align directly with the D-PLEX100 operational and launch plans. We believe that these milestones are achievable during the term of the agreement and are not a stacked structure designed to inflate the headline number. In addition to these milestone payments, PolyPid is entitled to tiered royalties on Azurity's sales in the U.S. and Canada, ranging from mid-teens to mid-20s percentages. PolyPid will manufacture and supply the product, generating an additional agreed transfer price on every unit supplied to Azurity.

Unlike most licensing deals in our industry, where the licensor participates only through royalties, we made a strategic choice several years ago to retain manufacturing globally. That choice now positions PolyPid to potentially capture a meaningful share of the ultimate end product economics. I want to make one broader point about the deal economics. A partnership structure like this one with multiple components can be complex, and we recognize that some observers may focus on any single component in isolation. Taken as a whole, however, we believe the combination of secured upfront event-driven milestones, tiered royalties, agreed transfer price on every manufactured unit, and an Azurity-funded label expansion pathway represent unusually strong economics for a company at our stage in commercialization partnership of this kind. Jonny will walk you through this architecture and its balance sheet implications in more detail shortly.

In preparation for the upcoming launch, we continue to advance our manufacturing and inspection preparations. Our facility has already passed four consecutive successful good manufacturing practice or GMP inspections, including the most recent one by the Israeli Ministry of Health in September 2025. During the commercial evaluation process, prospective commercial partners conducted on-site diligence at our site in Israel, providing external validation of our manufacturing readiness posture. Our team continues to work closely with experienced external consultants and has conducted multiple mock inspections in preparation for the FDA pre-approval inspection that will follow. We are entering this process from a position of strength and are highly focused on getting it right at first time. Turning to Europe. During the second quarter, we held meetings with the rapporteur and co-rapporteur, the European regulatory authorities designated to lead the assessment of our planned MAA for D-PLEX100.

These meetings were productive and positive, and we currently plan to submit the MAA to the European Medicines Agency in the third quarter of this year under the centralized procedure, which, if approved, will enable the product to be marketed across all EU member states. Before I hand the call over to Ori, I want to briefly summarize the key upcoming milestones that investors should be tracking over the coming quarters. First, the FDA pre-approval inspection of our manufacturing facility following NDA acceptance. Second, our goal date under PDUFA of November 28, 2026. Third, our planned MAA submission to the European Medicines Agency in the third quarter of this year. And fourth, the expected commercial launch of D-PLEX100 by Azurity in the United States in early 2027. With that, I will now turn the call over to Ori.

Ori? Thank you, Dikla. I would like to spend a few minutes on Azurity, on the joint launch preparation now underway, on the progress we have made around D-PLEX100 this quarter, and finally on our broader PLEX-Matrix technology opportunities beyond the Azurity partnership.