Greetings and welcome to the PolyPid second quarter 2026 conference call. As a reminder, this call is recorded and I would now like to introduce your host for today's conference, Yuda Liebler from ARCS Investor Relations. Mr. Liebler, you may begin.

Thank you, operator, and 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 Investors 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 Azordi 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 DPLEX-100 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 repertoire and co-repertoire regarding the planned marketing authorization application or MAA and the anticipated timing thereof, the expected commercial launch of D-Plex 100 by Azordi 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-Plex 100, The company's Kinatrix 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's my pleasure to turn the call over to Dikla Czaczkes Akselbrad, the CEO of PolyPID. Dikla?

Thank you, Yuda, 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 DIPLEX-100 with priority review. and second, the signing of an exclusive commercialization partnership with Azurity Pharmaceuticals for the United States and Canada. Starting with regulatory progress. During the second quarter, we completed the NDA submission for DPLEX-100 for the prevention of surgical site infection or SSI in patients undergoing abdominal colorectal 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 DIPTEX 100 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 up the DUFA goal date to November 28, 2026. Taken together and 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 DPLEX 100 over the last several years. Turning to our commercial partnerships. On July 17, 2026, we entered into an exclusive commercialization agreement with Azurity Pharmaceuticals for DPLEX-100 in the United States 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 Azurety 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 DPLEX 100 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 this milestone payment, PolyPID is entitled to tiered royalties on assurative sales in the U.S. and Canada. ranging from mid-teens to mid-twenties percentages. Polypid will manufacture and supply the product, generating an additional agreed transfer price on every unit supplied to Azurety. 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 position 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 authority-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 repertoire and co-repertoire, the European regulatory authorities designated to lead the assessment of our planned MEA for DPLEX 100. These meetings were productive and positive, and we currently plan to submit the MEA to the European Medicine 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 MEA submission to the European Medicine Agency in the third quarter of this year. The expected commercial launch of DIPLEX 100 by Azurety 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 Azurety, on the joint launch preparation now underway, on the progress we have made around DIPLEX 100 this quarter, and finally on our broader and Kinetrix Technology Opportunities and beyond the Azure ET partnership. Beginning with Azure ET. The partnership process that we have discussed on prior quarterly calls many times was focused on identifying a partner with the capabilities, focus and infrastructure to make D-Plex 100 a successful commercial product. This was a rigorous process and importantly, it was a highly competitive one. We engage with multiple potential commercial partners, all with robust hospital infrastructure, and several of those discussions progress to very advanced stages. In our judgment, Azurity emerged as the partner best positioned to lead the U.S. and Canada launch of Diglex 100. Azurity is an established specialty pharmaceutical company with a first-in-class commercial model and a portfolio of over 50 medicines spanning 10 therapeutic areas. Azuriti is backed by QHP Capital, a healthcare-focused private equity investor. Beyond Capital, we believe several elements of Azuriti's track record position them uniquely well to commercialize DIPLEX-100. Azuriti has an antibiotic on the market, which gives them established credibility with infectious disease specialists, a core audience for DIPLEX-100. Azuriti also markets bowel-prep products, in the exact same colorectal surgery call point the DPLEX-100 initially targets, giving them existing relationship with the same prescribers. And with more than 10 additional hospital-administered products already on the market, Azureity brings the GPO infrastructure, hospital contracting expertise, and institutional relationships that reach over 1,700 leading hospitals and academic institutions in the U.S. A food pit that takes years to build. With over 200 U.S. commercial-facing colleagues, just under 1,000 employees worldwide, and a specialty pharma orientation across hospitals and surgical channels, we believe Azure AD is uniquely positioned to reach the surgeons, infection specialists, hospital pharmacy directors, and value analysis committees who will drive DPLEX-100 adoption. Their dedicated hospital-facing and surgical-facing sales capabilities align directly with the way DPLEX-100 will be prescribed and administered in a way that few counterparties in our process could match. In short, Azure IT brings the scale, focus, and execution capability that we believe DPLEX-100 needs at launch. Beyond the initial licensed territories, Azurety has established commercial operations and partnerships spanning more than 50 countries. While the current agreement is focused on the US and Canada, Azurety's international infrastructure and experienced launching specialty medicine creates strategic optionality when additional geographic opportunities are pursued in the future. The joint work between our teams to prepare for launch is now well underway. We have established joint forums to align on medical, regulatory, and commercial preparation. Azure IT is leading on-the-ground commercial activities, including Salesforce build-out, national account planning, medical affairs, and pharmacy channel work, while PolyPay retains responsibility for global manufacturing and global regulatory strategies. This division of labor plays to each party's strengths. The partnership also includes a joint development framework funded by Azurity to pursue label expansion opportunities of DIPLEX-100 in additional indications beyond the abdominal indication. DIPLEX-100's mechanism and platform supports broader use across other SSI-relevant surgical settings, and Azurity's willingness to fund that expansion work is a strong signal of the commercial opportunity. Finally, I want to spend a moment on how we think about polypids growth drivers in the near and near term. The first growth driver is DPLEX-100 label expansion to additional surgical site infection indication beyond prevention of SSI in abdominal surgery. Significantly expanding the total addressable market to other areas of unmet needs such as C-section surgery and joint replacements. This level expansion will be funded by Azuriti through the joint development framework. The second growth driver is expanding DIPLEX 100 to other territories outside the US and Canada which are under authorities partnership. And finally, the third growth driver is the expansion of the pipeline under our kinetics technology over which PolyPig retains full ownership and which is where we see even broader significant long-term potential as we grow as a company. In terms of our pipeline, we are now exploring exciting areas that go beyond prevention and into treatment application. Our long-acting metabolic program is one such area we have previously discussed. We are also exploring high-value areas where we believe we can advance programs relatively quickly to the clinic by leveraging the clinical, manufacturing, and safety foundation we have already built for DIPLEX-1 funding. In many of these cases, we believe that the mechanistic NCMC platform we build around DPLEX-100 can materially compress the path to meaningful clinical stages for programs that would otherwise require years of de novo formulation and preclinical work. We look forward to sharing more on specific pipeline products as those plans develop. With that, I will now turn the call over to Jonny to review our financial performance for the quarter. Jonny?

Thank you, Ori. I will now walk through our financial results for the second quarter ended June 30th, 2026 and highlight the material developments impacting our balance sheet. Starting with the Azurety partnership, as Dikla noted, we have already secured $30 million in aggregate, upfront and near-term milestones from our partnership with Azurety. and are eligible for over $290 million in additional regulatory launch and sale milestones. On top of these payments, following commercial launch, we expect to generate two additional ongoing revenue streams. Tiered royalties on Azurety sales in the United States and Canada in a range from mid-teen to mid-twenties percentages and a transfer price on every unit we manufacture and supply to Azurety. The Label Expansion Program under the Joint Development Agreement is funded by Azurety and expands the addressable base for both revenue streams over time without requiring incremental polypeep capital. Turning to our income statement for the quarter, research and development expenses for the second quarter of 2026 were $6.1 million compared to $6.2 million in the second quarter of 2025. R&D activity in the second quarter of 2026 primarily reflects ongoing NDA-related activities and continued commercial readiness preparation. General and administrative expenses were $1.3 million compared to $2.5 million in the prior year period. The decrease was primarily due to the decrease of non-cash expenses related to performance-based options following the positive Phase III Shield II top-line results, which triggered the vesting of those options. Marketing and business development expenses were $0.5 million compared to $0.7 million in the prior year period. Net loss for the second quarter of 2026 was $7.8 million or $0.35 per share, compared to a net loss of $10 million or $0.78 per share in the second quarter of 2025. For the first six months of 2026, net loss was $15.6 million, compared to $18.2 million in the first six months of 2025. Turning to the balance sheet, as of June 30th, 2026, PolyFeed had $6.6 million in cash and cash equivalents, compared to $12.9 million of cash, cash equivalents, and short-term deposits at December 31st, 2025. Subsequent to quarter end, our capital position has been further strengthened by $15 million upfront payment from authority at signing, and the additional $15 million as a result of the FDA acceptance of the NDA filing. Looking at our remaining warrant position, the only warrants outstanding are the warrants issued in June 2025, of which approximately 7.3 million remain outstanding, with an expiration date in June 2027. These warrants are by their terms stapled to the shares issued in June 2025, meaning that if a holder sells or transfers those shares prior to exercise of the new warrants, the corresponding new warrants are forfeited. We view this structure as a meaningful alignment mechanism with our long-term shareholder base. Taken together, we believe this puts the company in a materially stronger financial position today than at any prior point in the DPLEX 100 development journey. While also providing a streamlined and healthier capital structure for Polypeet and our shareholders, based on our current plans and assumptions, we expect our existing cash resources together with the expected proceeds from our recently announced commercialization agreement as well as future potential proceeds will be sufficient to fund operations into 2028 and through several significant upcoming potential milestones. And we do not have immediate financing needs in the near future. With that, we will now open the call for questions. Operator?

Thank you. We will now begin the question and answer session. If you wish to ask a question, you will need to press star 1 1 on your telephone and wait for your name to be announced. To withdraw your question, please press star 1 1 again. We will take our first question. Your first question comes from Chase Knickerbocker from Craig Helen. Please go ahead, your line is open.

Good morning. Congrats on all the progress here and thanks for taking the questions. Maybe just first for me on, you know, kind of upcoming expected inspection. Has FDA communicated anything to you as it relates to the potential timing of your pre-approval inspection? And then as a part of the deal with Azzurri would love to hear the sort of work that went into them getting comfortable on the CMC side. Did they do a fairly strenuous kind of mock audit kind of series as a part of the due diligence? Thanks.

Hi, Chase. Thank you and good morning. So with regards to our communication with the FDA, we had since we submitted We had several back and forth communication and different aspects, including things that are relating to the different audits that are expected as part of the NDA review. I don't think it makes sense to go into more detail, but I could say that we see the process as very effective and efficient. As you would expect from a priority review which leaves both the agency and the sponsor a relatively short time to review everything, so we are Super cooperative with any request that is coming from the FDA to meet the timeline. And I wouldn't go into specific dates on specific requests, but as I said, we had several communication from the time that we submit, including communication relating to the different audits that are expected. With regards to the CMC, That's something we tried to highlight in the formal portion by highlighting both the work that we did with Azurety but also with other potential partners that we had at the time. And as Ori mentioned, we had on-site due diligence in the Israeli side. by the Azuriti team and by others that were competing for this asset to see both the facility, the CMC processes, the package, everything that could give a potential partner the comfort that this product will be approved and we as a partner could manufacture on a commercial scale, and support the launch of the product. So from that perspective, we're very confident that we had several, you could say, external validation, both from other regulatory inspection that we did, the potential partners, including Azurety, as well as a mock inspection that we have performed with external advisors.

Got it. And maybe just last for me, would just like to understand kind of the level of overlap that existing Azurety reps have, you know, into that kind of colorectal and general surgeon call point. You know, how many reps are kind of calling on those physicians today in their kind of hospital focus segment? And do you have any idea At this stage, how many of those 200 customer-facing representatives that you mentioned will have D-Plex in the bag at launch?

Thanks. Hi, Chase. I can take some of that. So we can't really break down Azurite as a sales team. But they do already call, as you said, they do already call all colorectal surgeons and in other areas in the hospital. That's kind of one part of it. The other part is they have a significant buildup to expand the capabilities that they have in preparation for the launch. They build up in the market access piece, in the contracting piece, and on the medical team. So they are putting a lot of effort ahead of this launch. Like I mentioned earlier, they are already in 1,700 hospitals and academic centers. That's their target. Obviously, not all on day one. There will be gradual hospital by hospital and IDN by IDN kind of a stepwise approach, but this is the coverage that they're going for. Great. Thanks and congrats again.

Thank you, Jason.

Thank you. We will take our next question. Your next question comes from Jason Butler from Citizens. Please go ahead. Your line is open.

Hi, thanks for taking the questions. A couple on the AZERTI partnership. On the commercial side, obviously it's only been a short period of time, but what are you already doing with AZERTI to get them ready for the launch? You've obviously done a lot of pre-commercial work. What are they now doing to prepare for the D-Plus 100 launch? and then second on the development side, how are you thinking about the initial label expansion efforts and how quickly under this collaboration could additional trials begin for additional indications? Thank you.

I'll take the first piece. So a few points here. First, Zuriti has been planning, we've been in conversation with them for periods of time now and they, They haven't started just three weeks ago. They've been thinking about this for a while now. And so they're really hitting the ground running on taking ownership of a lot of these activities. So we've transferred a lot of the knowledge, studies that were done, market research, pricing, KOLs that were done, assessments of NTAP and so on. So this was handed over, and they have their own plans in place to take and expand. So we know NTAP is coming. That's one thing. We know we're building a network of KOL. The American College of Surgeons conference is this week. Authority is there. ID week is in a couple of months. Authority will be there trying to build this network. and some of the activities that can be done before approval, some of the prior approval, access conversations and after approval MSLs on the ground reaching out to PIs and reaching out to KOLs and start kind of discussing and introducing the product. So all these plans are in place, the marketing team is in place, the contracting team is in place and so that's That's really, like I said, we're not starting at step zero. We're starting at step four here.

Hi, Jason. Good morning. With regards to the label expansion, the joint development framework is scoped around DIPLEX-100, an additional surgical site infection indication behind the initial abdominal indication, obviously. And we will first need to see with the FDA what will be the final indication. But what I can say is that the indication commonly identified as our top target is consistent with the way Azurity sees it. So what we have discussed really publicly for years, think about cardiac procedure, specifically CABG, orthopedic, including hip and knee, and breast mastectomy and reconstruction. Those are the top indication that we view and Azuriti view as few of the top that should be pursued.

Great. Thanks for taking the questions, and congrats again on all the progress. Thank you.

Thank you. We will take our next question. Your next question comes from the line of Bubalam Peshayappan from Roth Capital Partners. Please go ahead. Your line is open.

Hi, good morning. Thanks for taking your questions. Maybe can you discuss the key KPIs you would use internally to track the DPEX 100 launch sectors? Let's say, are you going to track, obviously you're going to track formula events, but ultimately, you know, what are the key KPIs that you want to do, you know, like target activation of hospital surgeon users? Can you elaborate more on that? So, there are a couple of things here that will be reviewed. Some of it is coming from Looking at the collaboration and the partnership that we have and some of the authority commitments that is in the agreement and the minimums that are part of the structure of the agreement. So this is obviously something that we will monitor. There will be also aspects relating to hospital. and specifically within the hospital P&T committees, a number of hospitals that are approving or adding to the pharmacy the drug. And you should also think about things that are part of a drug like this, things like NTAP and progress around The reimbursement and the conversation with payers, this is the third compound. Ori, would you want to add anything?

I think we will view, so obviously, as Dikla mentioned, the stepwise approach, seeing month by month how many hospitals are added, where P&T reviews review the product, and then if there's a pilot studies that are done and a doctor's usage. Yeah, I think those will be the initial ones to see really how successful, let's say the first 12 months from launch, this will be the main benchmark.

All right, thanks for that. Let's say the drug is indeed launched in first quarter 27.

Can you discuss when would the revenue be recognized?

So we indicated that it's early 2027 and we will be recognizing revenue quite immediately because as you probably remember, one of the compound of the structure of the deal is the pre-negotiated transfer price per vial. So every vial that we will sell, we will, to Azurety, we will recognize revenues there. There will be the second compound on royalties and milestones, and those will be recognized as they come. Okay, maybe one final question from me. So you indicated that the EMA submission is targeted in third quarter 26. So can you maybe provide us a sense of the receptivity to the clinical package during your dialogue with them? Are there any concerns that they raised about clinical or statistics or safety and things like that? So it was very important. First, thank you for this question. I think it's very important also when, again, Looking at the strength of our regulatory package, we had two meetings during the quarter with the repertoire and the co-repertoire. Those meetings are the equivalent to a pre-NDA meeting at the FDA. And the purpose of the meeting was similar to a pre-NDA meeting, to align the requirement, to align the timeline. For us, it was very productive. We heard, I wouldn't say changes, but more, you know, each regulatory arm has their own sensitive area where they want to see additional or where they put the focus, and this was very helpful for us to accommodate. but you could understand from the timeline of the fact that we met them towards the end of June and we are submitting the package before the end of this quarter that nothing there was major that required any additional data or changes to the package that will delay the submission timeframe.

Great.

All right, congratulations on your progress. Thank you. Thank you. Thank you so much.

Thank you. Once again, if you wish to ask a question, please press star 1, 1 on your telephone. We will take our next question, and your question comes from the line of Brandon Foulkes from HC Wainwright. Please go ahead, your line is open.

Hi, thanks for taking my questions, and congrats on all the progress. Maybe just two from me. Can you just talk about the earlier PDUFA date and what that does in terms of Ability to supply the markets or launch date, you know, you still expect a 1Q launch. And then similarly, you know, with the November PDUFA date, any impact on the NTAP process there in terms of when it could come online for DPLEX-100? Thank you.

So first, as you can imagine, since we knew that the product has a breakthrough therapy designation and could be eligible for a priority review, We prepared for both scenarios. We prepared for a before-end-of-the-year approval PDUFA date and early 2027 PDUFA date. So we prepared both in terms of NDA submission, getting ready for all the audits, whether it's the GCP or the GMP, as well as the launch. So from our perspective, having the PDUFA date earlier than anticipated doesn't change anything. And we were very happy with that. I think it's again showed the strength of the package and the potential that the product has to improve both the effectiveness and safety of the treatment. As for the QIDP, there are a couple of things. The NTAP, sorry, I said.

Let me take that. So the NTAP, first, the product does not need to be approved to submit the NTAP. It just needs to be under review with the FDA. So from that point, we have no No issue, and Azure ETA is working to be on the next year's financial year, governmental financial year. The deadline is October, and this is what Azure ETA is working towards.

Brendan, anything else? Random folks, your line is open.

As there seems to be no response, this concludes today's question and answer session. I will now hand back for closing remarks.

Thank you for joining PolyPID's second quarter 2026 earnings conference call. This has been a defining quarter for PolyPID and we are highly confident In our long-term prospect, especially the potential of DIPLEX 100 in the hands of Azurety as our commercial partner in the United States and Canada and the broader kinetics technology behind it. As we look ahead to the November 28th PDUFA goal date and the expected commercial launch of DIPLEX 100 in early 2027, we are grateful for our team members, We look forward to speaking with you again on our next conference call. This concludes today's conference call. Thank you for participating. You may now disconnect.