PolyPid Q2 2026 Earnings Report

PolyPid EPS Results

• Actual EPS: -$0.35
• Consensus EPS: -$0.38
• Beat/Miss: Beat by +$0.03
• One Year Ago EPS: N/A

PolyPid Revenue Results

• Actual Revenue: N/A
• Expected Revenue: $0.30 million
• Beat/Miss: N/A
• YoY Revenue Growth: N/A

PolyPid Announcement Details

• Quarter: Q2 2026
• Date: 8/12/2026
• Time: Before Market Opens
• Conference Call Date: Wednesday, August 12, 2026
• Conference Call Time: 8:30AM ET

PolyPid (NASDAQ:PYPD) Ltd is a clinical‐stage biotechnology company focused on polymer‐based drug delivery technologies designed to enhance the performance of therapeutic agents at mucosal surfaces. Leveraging its proprietary Mucoadhesive & Mucus‐Penetrating (MMP) platform, PolyPid develops long‐acting formulations for ocular, oral and pulmonary indications. Its lead candidates include OncoTears and OralTear, therapies targeting dry eye and dry mouth conditions, respectively, as well as Paclical, a polymer‐formulated paclitaxel designed to improve tolerability and antitumor activity in oncology patients.

Founded in 2003 and headquartered in Jerusalem, Israel, PolyPid has assembled an international patent portfolio covering key markets in North America, Europe and Asia. OncoTears has received marketing authorization in select countries of the former CIS, and the company is advancing regulatory filings for its lead assets in the United States and European Union. Research and clinical operations are conducted in Israel, with strategic collaborations established to support commercialization efforts and late‐stage clinical trials in multiple geographies.

Under the leadership of co-founder and Chief Executive Officer Yoel Hakim, PolyPid’s management team brings together expertise in polymer chemistry, pharmacology and regulatory affairs. As a Nasdaq‐listed entity, the company remains focused on driving its clinical programs toward pivotal studies, while exploring new therapeutic applications of its mucus‐penetrating delivery platform to address unmet medical needs across a range of mucosal diseases.

PolyPid Q2 2026 Earnings Call Transcript

Key Takeaways

• Positive Sentiment: FDA accepted D-PLEX100’s NDA for filing with priority review and no filing-review issues identified; the PDUFA goal date is November 28, 2026.
• Positive Sentiment: PolyPid signed an exclusive U.S. and Canadian commercialization agreement with Azurity, securing $30 million in upfront and near-term milestones, eligibility for more than $290 million in additional milestones, tiered royalties, and a transfer price on manufactured units.
• Positive Sentiment: Azurity has begun launch preparations, including sales-force expansion, hospital contracting, medical affairs, and reimbursement efforts, with a commercial launch still expected in early 2027. The partnership will also fund label-expansion development in additional surgical indications.
• Positive Sentiment: Management expects its cash resources, partnership proceeds, and potential future payments to fund operations into 2028, and said it has no immediate financing needs.
• Neutral Sentiment: PolyPid plans to submit D-PLEX100’s marketing authorization application to the European Medicines Agency in the third quarter of 2026 and is preparing for the FDA pre-approval manufacturing inspection; management reported productive regulatory discussions but approval remains subject to review.

Presentation

[Operator]

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

[Yehuda Leibler, Head of Investor Relations at PolyPid]

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.

[Yehuda Leibler, Head of Investor Relations at PolyPid]

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.

[Yehuda Leibler, Head of Investor Relations at PolyPid]

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.

[Yehuda Leibler, Head of Investor Relations at PolyPid]

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?

[Dikla Czaczkes Akselbrad, CEO at PolyPid]

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.

[Dikla Czaczkes Akselbrad, CEO at PolyPid]

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.

[Dikla Czaczkes Akselbrad, CEO at PolyPid]

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.

[Dikla Czaczkes Akselbrad, CEO at PolyPid]

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.

[Dikla Czaczkes Akselbrad, CEO at PolyPid]

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.

[Dikla Czaczkes Akselbrad, CEO at PolyPid]

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.

[Dikla Czaczkes Akselbrad, CEO at PolyPid]

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?

[Ori Warshavsky, COO at PolyPid]

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. Beginning with Azurity, 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-PLEX100 a successful commercial product. This was a rigorous process, and importantly, it was a highly competitive one. We engaged with multiple potential commercial partners, all with robust hospital infrastructure, and several of those discussions progressed to very advanced stages. In our judgment, Azurity emerged as the partner best positioned to lead the U.S. and Canada launch of D-PLEX100.

[Ori Warshavsky, COO at PolyPid]

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. Azurity is backed by QHP Capital, a healthcare-focused private equity investor. Beyond capital, we believe several elements of Azurity's track record position them uniquely well to commercialize D-PLEX100. Azurity has an antibiotic on the market, which gives them established credibility with infectious disease specialists, a core audience for D-PLEX100. Azurity also markets bowel prep products in the exact same colorectal surgery core point that D-PLEX100 initially targets, giving them existing relationships with the same prescribers. With more than 10 additional hospital-administered products already on the market, Azurity 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 footprint that takes years to build.

[Ori Warshavsky, COO at PolyPid]

With over 200 U.S. commercial-facing colleagues, just under 1,000 employees worldwide, and a specialty pharma orientation across hospital and surgical channels, we believe Azurity is uniquely positioned to reach the surgeons, infection specialists, hospital pharmacy directors, and value analysis committees who will drive D-PLEX100 adoption. Their dedicated hospital-facing and surgical-facing sales capabilities align directly with the way D-PLEX100 will be prescribed and administered in a way that few counterparties in our process could match. In short, Azurity brings the scale, focus, and execution capability that we believe D-PLEX100 needs at launch. Beyond the initial licensed territories, Azurity has established commercial operations and partnerships spanning more than 50 countries. While the current agreement is focused on the U.S. and Canada, Azurity's international infrastructure and experience launching specialty medicines creates strategic optionality when additional geographic opportunities are pursued in the future.

[Ori Warshavsky, COO at PolyPid]

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. Azurity is leading on-the-ground commercial activities, including sales force build-out, national account planning, medical affairs, and pharmacy channel work, while PolyPid retains responsibility for global manufacturing and global regulatory strategy. This division of labor plays to each party's strength. The partnership also includes a joint development framework funded by Azurity to pursue label expansion opportunities of D-PLEX100 in additional indications beyond the abdominal indication. D-PLEX100'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 PolyPid's growth drivers in the near and mid-term.

[Ori Warshavsky, COO at PolyPid]

The first growth driver is D-PLEX100 label expansion to additional surgical site infection indications beyond prevention of SSI in abdominal surgery, significantly expanding the total addressable market to other areas of unmet need, such as C-section surgery and joint replacement. This label expansion will be funded by Azurity through the joint development framework. The second growth driver is expanding D-PLEX100 to other territories outside the U.S. and Canada, which are under Azurity's partnership. Finally, the third growth driver is the expansion of the pipeline under our PLEX technology, over which PolyPid 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 applications. Our long-acting metabolic program is one such area we have previously discussed.

[Ori Warshavsky, COO at PolyPid]

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 D-PLEX100. In many of these cases, we believe that the mechanistic and CMC platform we built around D-PLEX100 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 evolve. With that, I will now turn the call over to Jonny to review our financial performance for the quarter. Jonny?

[Jonny Missulawin, CFO at PolyPid]

Thank you, Ori. I will now walk through our financial results for the second quarter ended June 30, 2026, and highlight the material developments impacting our balance sheets. Starting with the Azurity partnership, as Dikla noted, we have already secured $30 million in aggregate upfront and near-term milestones from our partnership with Azurity, 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 Azurity sales in the United States and Canada in a range from mid-teen to mid-20s percentages, and a transfer price on every unit we manufacture and supply to Azurity. The label expansion program under the joint development agreement is funded by Azurity and expands the addressable base for both revenue streams over time without requiring incremental PolyPid capital.

[Jonny Missulawin, CFO at PolyPid]

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.

[Jonny Missulawin, CFO at PolyPid]

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 30, 2026, PolyPid had $6.6 million in cash and cash equivalents compared to $12.9 million of cash equivalents, and short-term deposits at December 31, 2025. Subsequent to quarter end, our capital position has been further strengthened by $15 million upfront payment from Azurity at signing and the additional $15 million as a result of the FDA acceptance of the NDA filings. 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.

[Jonny Missulawin, CFO at PolyPid]

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 D-PLEX100 development journey, while also providing a streamlined and healthier capital structure for PolyPid 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. We do not have immediate financing needs in the near future.

[Jonny Missulawin, CFO at PolyPid]

With that, we will now open the call for questions. Operator?

[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 one one on your telephone and wait for your name to be announced. To withdraw your question, please press star one one again. We will take our first question. Your first question comes from Chase Knickerbocker from Craig-Hallum. Please go ahead. Your line is open.

[Chase Knickerbocker, Analyst at Craig-Hallum]

Good morning. Congrats on all the progress here, and thanks for taking the questions. Maybe just first for me on upcoming expected inspection. Has FDA communicated anything to you as it relates to the potential timing of your pre-approval inspection? As a part of the deal with Azurity, 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.

[Dikla Czaczkes Akselbrad, CEO at PolyPid]

Hi, Chase. Thank you, and good morning. With regards to our communication with the FDA, since we submitted the NDA, we had several back-and-forth communication in 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. We are super cooperative with any request that is coming from the FDA to meet the timeline. I wouldn't go into specific dates on specific requests, but as I said, we had several communication from the time that we've submit, including communication relating to the different audits that are expected.

[Dikla Czaczkes Akselbrad, CEO at PolyPid]

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 Azurity, but also with other potential partner that we had at the time. As Ori mentioned, we had on-site due diligence in the Israeli site by the Azurity team and by other 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. 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 Azurity, as well as a mock inspection that we have performed with external advisors.

[Chase Knickerbocker, Analyst at Craig-Hallum]

Got it. Maybe just last for me, would just like to understand kind of the level of overlap that existing Azurity reps have into that kind of colorectal and general surgeon call point. How many reps are kind of calling on those physicians today in their kind of hospital-focused segment? 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.

[Ori Warshavsky, COO at PolyPid]

Yeah. Hi, Chase. I can take some of that. We can't really break down Azurity's sales team. But they do already call, as you said, they do already call colorectal surgeons and in other areas in the hospital. That's kind of one part of it. The other part is they have a kind of significant build-up to expand the capabilities that they have in preparation for the launch, and a build-up in the market access piece, in the contracting piece, and on the medical team. They are putting a lot of efforts 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'll be gradual hospital by hospital and IDN by IDN kind of a step-wise approach, but this is the coverage that they're going for.

[Chase Knickerbocker, Analyst at Craig-Hallum]

Great. Thanks, and congrats again.

[Dikla Czaczkes Akselbrad, CEO at PolyPid]

Thank you, Chase.

[Operator]

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

[Jason Butler, Analyst at Citizens]

Hi. Thanks for taking the questions. A couple on the Azurity partnership. On the commercial side, obviously, it's only been a short period of time, but what are you already doing with Azurity 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-PLEX100 launch? 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.

[Ori Warshavsky, COO at PolyPid]

I'll take the first piece.

[Dikla Czaczkes Akselbrad, CEO at PolyPid]

You take the first. Yeah.

[Ori Warshavsky, COO at PolyPid]

A few points here. First, Azurity has been planning. We've been in conversation with them for a period of time now, and they haven't started just three weeks ago. They've been thinking about this for a while now. They're really hitting the ground running on taking ownership of a lot of these activities. 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. This was handed over and they have their own plans in place to take and expand. We know NTAP is coming, that's one thing. We know we're building a network of KOLs. The American College of Surgeons Clinical Congress is this week, Azurity is there. IDWeek is in a couple of months, Azurity will be there trying to build this network.

[Ori Warshavsky, COO at PolyPid]

And some of the activities that can be done before approval, some of the prior approval, access conversations and after approval, Medical Science Liaisons on the ground, reaching out to Principal Investigators 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, so that's really, like I said, we're not starting at step zero, we're starting at step four.

[Dikla Czaczkes Akselbrad, CEO at PolyPid]

And hi, Jason. Good morning. With regards to the label expansion, the joint development framework is scoped around D-PLEX100 and 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 Azurity view as few of the top that should be pursued.

[Jason Butler, Analyst at Citizens]

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

[Dikla Czaczkes Akselbrad, CEO at PolyPid]

Thank you.

[Operator]

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

[Boobalan Pachaiyappan, Analyst at Roth Capital Partners]

Hi. Good morning. Thanks for taking our questions. Maybe can you discuss the key KPIs you would use internally to track the D-PLEX100 launch success? Let's say, obviously you are going to track formulary events, but ultimately, what are the key KPIs that you wanted to target? Activation of hospitals, surgeon users. Can you elaborate more on that?

[Dikla Czaczkes Akselbrad, CEO at PolyPid]

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 Azurity commitments that is in the agreement, and the minimums that are part of the structure of the agreement. This is obviously something that we will monitor. There will be also aspect relating to hospital and specifically within the hospital P&T committees and number of hospitals that are approving or adding to the pharmacy, the drug. 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?

[Ori Warshavsky, COO at PolyPid]

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

[Boobalan Pachaiyappan, Analyst at Roth Capital Partners]

All right. Thanks for that. Let's say the drug is indeed launched in first quarter 2027.

[Dikla Czaczkes Akselbrad, CEO at PolyPid]

Sure.

[Boobalan Pachaiyappan, Analyst at Roth Capital Partners]

Can you discuss.

[Dikla Czaczkes Akselbrad, CEO at PolyPid]

Yeah, sure.

[Boobalan Pachaiyappan, Analyst at Roth Capital Partners]

When would the revenue be recognized?

[Dikla Czaczkes Akselbrad, CEO at PolyPid]

We indicated that it is early 2027. We will be recognizing revenue quite immediately because, as you probably remember, one of the compound of the structure of the deal is the prenegotiated transfer price per vial. Every vial that we will sell to Azurity, we will recognize revenues there. There will be the second compound on royalties and milestone, and those will be recognized as they come.

[Boobalan Pachaiyappan, Analyst at Roth Capital Partners]

Okay, maybe one final question from me. You indicated that the EMA submission is targeted in Q3 2026.

[Dikla Czaczkes Akselbrad, CEO at PolyPid]

Yes.

[Boobalan Pachaiyappan, Analyst at Roth Capital Partners]

Can you maybe provide us a sense of the receptivity to the clinical package during your dialogue with them? Were there any concerns that they raised about clinical or statistics or safety and things like that?

[Dikla Czaczkes Akselbrad, CEO at PolyPid]

First, thank you for this question. I think it is very important also when, again, looking at the strength of our regulatory package. We had two meetings during the quarter with the rapporteur and the co-rapporteur. 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 would not say changes, but more, 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.

[Dikla Czaczkes Akselbrad, CEO at PolyPid]

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.

[Boobalan Pachaiyappan, Analyst at Roth Capital Partners]

Great. All right. Congratulations on your progress.

[Dikla Czaczkes Akselbrad, CEO at PolyPid]

Thank you. Thank you so much.

[Operator]

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

[Brandon Folkes, Analyst at H.C. Wainwright]

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 market or launch date? Do you still expect a 1Q launch? Then similarly, with the November PDUFA date, any impact on the NTAP process there in terms of when it could come online for D-PLEX100? Thank you.

[Dikla Czaczkes Akselbrad, CEO at PolyPid]

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 scenario. 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. From our perspective, having the PDUFA date earlier than anticipated doesn't change anything, and we were very happy with that. I think it, again, showed the strength of the package and the potential 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.

[Ori Warshavsky, COO at PolyPid]

Yeah. Maybe let me take that. 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. From that point, we have no issue, and Azurity is working to be on the next year's governmental financial year. The deadline is October, and this is what Azurity working towards. Brandon, anything else?

[Operator]

Brandon Folkes, 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.

[Dikla Czaczkes Akselbrad, CEO at PolyPid]

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 D-PLEX100 in the hands of Azurity as our commercial partner in the U.S. and Canada, and the broader PLEX technology behind it. As we look ahead to the November 28 PDUFA goal date and the expected commercial launch of D-PLEX100 in early 2027, we are grateful for our team members, shareholders, and all external partners for their commitment to our mission and support in continuing to advance toward our goal of bringing D-PLEX100 to healthcare providers and patients as quickly as possible. We look forward to speaking with you again on our next conference call.

[Operator]

This concludes today's conference call. Thank you for participating. You may now disconnect.

Participants

Executives

• Yehuda Leibler, Head of Investor Relations
• Dikla Czaczkes Akselbrad, CEO
• Ori Warshavsky, COO
• Jonny Missulawin, CFO

Analysts

• Chase Knickerbocker, Analyst at Craig-Hallum
• Jason Butler, Analyst at Citizens
• Boobalan Pachaiyappan, Analyst at Roth Capital Partners
• Brandon Folkes, Analyst at H.C. Wainwright