PYPD

Image source: The Motley Fool. Wednesday, Aug. 12, 2026 at 8:30 a.m. ET Chief Executive Officer - Dikla Czaczkes Akselbrad Chief Financial Officer - Jonny Missulawin Chief Operating Officer, U.S. - Ori Warshavsky Arx Investor Relations - Yehuda Leibler Operator: Greetings, and welcome to the PolyPid's 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, Yehuda Leibler, from Arx Investor Relations. Mr. Liebler, you may begin. Yehuda Leibler: 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 3 and 6 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 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 Kynatrix 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? Dikla Akselbrad: 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 United States 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 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 D-PLEX100 a Priority Review. This is a designation the agency reserves for drug candidate that in its judgment has 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 6 months, and it sets our PDUFA 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 D-PLEX100 over the 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 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 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 this milestone payment, PolyPid is entitled to tiered royalties on Azurity 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 have 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 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 MAA submission to the European Medicine 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: 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 Kynatrix 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 trial. 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. 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 health care-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 specialist. The core audience for D-PLEX100, Azurity also markets bowel prep products in the exact same colorectal surgery call point that D-PLEX100 initially target, giving them existing relationship with the same prescribers. And 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. 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 license 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. 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 part of the 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 midterm. 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 partnership. And finally, the third growth driver is the expansion of the pipeline under our Kynatrix 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. 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: 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 sheet. 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 the range from mid-teens 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. 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 noncash expenses related to performance-based options following the positive Phase III SHIELD II topline 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 6 months of 2026, net loss was $15.6 million compared to $18.2 million in the first 6 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, 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 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 transfer 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. And we do not have immediate financing needs in the near future. With that, we will now open the call for questions. Operator? Operator: [Operator Instructions] Your first question comes from Chase Knickerbocker from Craig-Hallum. Chase Knickerbocker: Congrats on all the progress here. Maybe just first for me on 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 Azurity, would love to hear the sort of work that went into them getting comfortable on the CMC side, do they -- did they do a fairly strenuous kind of mock audit kind of series as a part of the due diligence? Dikla Akselbrad: So 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. 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 request. But as I said, we had several communication from the time that we have submitted, 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 Azurity, but also with other potential partner that we had at the time. And as Ori mentioned, we had on-site due diligence in the Israeli site by the Azurity 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 are very confident that we had several, you could say, external validation, both from other regulatory inspection that we did, the potential partner including -- partners including Azurity as well as mock inspection that we have performed with external advisers. Chase Knickerbocker: Got it. And maybe just last for me. I 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? 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? Ori Warshavsky: Yes, I can take some of that. So we can't really break down the Azurity sales team. But they do already call -- as we said, they do already call upon 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 and buildup in the market access piece and the contracting piece and on the medical team. So 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 1. There will be a gradual hospital-by-hospital and IDN-by-IDN kind of a stepwise approach, but this is the coverage that they're going for. Operator: Your next question comes from Jason Butler from Citizens. Jason Butler: 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? 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? Ori Warshavsky: I'll take the... Dikla Akselbrad: You take the first -- yes. Ori Warshavsky: The first piece. So a few points here. First, Azurity has been planning -- we've been in conversation with them for a period of time now, and they -- they've not started -- they haven't filed just 3 weeks ago. They have 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, Azurity is there. IDWeek is in a couple of months, Azurity 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 really -- Like I said, we're not starting at step zero. We're starting at step 4. Dikla Akselbrad: With regards to the label expansion, the joint development framework work 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 a few of the top that should be pursued. Operator: Your next question comes from the line of Boobalan Pachaiyappan from ROTH Capital Partners. Boobalan Pachaiyappan: Maybe can you discuss the key KPIs you would use internally to track the D-PLEX100 launch success? Let's say, are you going to track -- obviously, you're going to track formulary events, but ultimately, what are the key KPIs that you wanted to like target, activation of hospitals, surgeon users? Can you elaborate more on that? Dikla Akselbrad: 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 Azurity commitments that is in the agreement that -- 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 their -- 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? Ori Warshavsky: [indiscernible] view -- So obviously, as Dikla mentioned, the stepwise approach seeing month by month how many hospitals get -- are added, where P&T reviews are review the product and then if there's pilot studies that are done and doctor's usage. Yes, 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 in the main benchmark. Boobalan Pachaiyappan: Let's say, the drug is indeed launched in first quarter '27. Can you discuss when would this revenue be recognized? Dikla Akselbrad: So we indicated that it's early 2027. And we will be recognizing revenue quite immediately because as you probably remember, one of the compounds of the structure of the deal is the pre-negotiated transfer price per vial. So every vial that we will sell we will -- 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: 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 have raised about clinical or statistics for safety and things like that? Dikla Akselbrad: So it was very -- 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 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 had, I wouldn't 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. 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 time frame. Operator: [Operator Instructions] We will take our next question and your question comes from the line of Brandon Folkes from H.C. Wainwright. Brandon Folkes: 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? And 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? Dikla Akselbrad: 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 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 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 again shows 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 -- in the NTAP, sorry, I said... Ori Warshavsky: Yes. 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 issue. And Azurity is working the -- to get the -- to be on the next year's financial year -- governmental financial year, the deadline is October, and this is what Azurity is working towards. Brandon, anything else? Operator: As there seems to be no response, this concludes today's question-and-answer session. I will now hand back for closing remarks. Dikla Akselbrad: 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 prospects, especially the potential of D-PLEX100 in the hands of Azurity as our commercial partner in the United States and Canada and the broader Kynatrix 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 health care 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. 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FDA Accepted D-PLEX₁₀₀ NDA with Priority Review; PDUFA Goal Date of November 28, 2026, Approximately One Quarter Ahead of Previously Communicated Guidance Exclusive U.S. and Canada Commercialization Partnership with Azurity Pharmaceuticals; $30 Million in Upfront and Near-Term Milestones Achieved Following NDA Acceptance, with Over $290 Million in Additional Milestones Plus Tiered Royalties Up to Mid-Twenties Percentages Potential U.S. Commercial Launch of D-PLEX₁₀₀ by Azurity Targeted for Early 2027 Conference Call Scheduled for Today at 8:30 AM ET PETACH TIKVA, Israel, Aug. 12, 2026 (GLOBE NEWSWIRE) -- PolyPid Ltd. (Nasdaq: PYPD) ("PolyPid" or the "Company"), an innovative biopharmaceutical company dedicated to improving patient outcomes by elevating treatment effectiveness, right where care begins, today provided a corporate update and reported financial results for the three and six months ended June 30, 2026. Recent Corporate Highlights: Completed NDA Submission for D-PLEX₁₀₀ and Received FDA Acceptance with Priority Review: Exclusive U.S. and Canada Commercialization Partnership with Azurity Pharmaceuticals: Advancing EU Regulatory Submission: Advancing Kynatrix™ Pipeline Beyond D-PLEX₁₀₀: Upcoming Expected Milestones: "The second quarter of 2026 and the first few weeks of the third quarter completed PolyPid's transition into a commercial-stage company, with the acceptance by the FDA with Priority Review of our NDA submission for D-PLEX₁₀₀, with no filing review issues and a PDUFA goal date meaningfully ahead of the guidance we have previously communicated," said Dikla Czaczkes Akselbrad, Chief Executive Officer of PolyPid. "In parallel, the U.S. and Canada commercial partnership we entered into in July, together with the immediate $30 million from the partnership, places PolyPid in potentially the strongest financial position in the Company’s history, with no immediate financing needs. With the NDA review process on track, our substantially strengthened financial position, and our U.S. and Canada commercial partnership with Azurity, we believe PolyPid is well positioned to advance D-PLEX₁₀₀ for abdominal colorectal surgery and, over time, additional broader surgical indications." Financial Results for the Three Months Ended June 30, 2026 Research and development expenses for the three months ended June 30, 2026, were $6.1 million, compared to $6.2 million in the same three-month period of 2025. Research and development activity in the second quarter of 2026 primarily reflects ongoing NDA-related activities and continued commercial readiness preparation. General and administrative expenses for the three months ended June 30, 2026, were $1.3 million, compared to $2.5 million for the same period of 2025. The decrease was primarily due to the decrease of non-cash expenses related to performance-based options ("PSUs") following the positive Phase 3 SHIELD II topline results, which triggered the vesting of those PSUs. Marketing and business development expenses for the three months ended June 30, 2026, were $0.5 million, compared to $0.7 million for the same period of 2025. For the three months ended June 30, 2026, the Company had a net loss of $7.8 million, or $(0.35) per share, compared to a net loss of $10.0 million, or $(0.78) per share, in the three-month period ended June 30, 2025. Financial Results for the Six Months Ended June 30, 2026 Research and development expenses for the six months ended June 30, 2026, were $11.9 million, compared to $12.3 million in the same six-month period of 2025. The decrease primarily reflects the completion of the SHIELD II Phase 3 trial and the Company's transition toward regulatory submission and commercial readiness activities. General and administrative expenses for the six months ended June 30, 2026, were $2.9 million, compared to $3.7 million for the same period of 2025. The decrease was primarily due to the decrease of non-cash PSU vesting expenses. Marketing and business development expenses for the six months ended June 30, 2026, were $0.9 million, compared to $1.0 million for the same period of 2025. For the six months ended June 30, 2026, the Company had a net loss of $15.6 million, or $(0.70) per share, compared to a net loss of $18.2 million, or $(1.48) per share, in the six-month period ended June 30, 2025. Balance Sheet Highlights As of June 30, 2026, the Company had cash and cash equivalents of $6.6 million, compared to cash, cash equivalents and short-term deposits of $12.9 million on December 31, 2025, not including $30 million in upfront and near-term milestone payments from Azurity, substantially strengthening the Company's balance sheet as it approaches the November 28, 2026 PDUFA goal date and prepares for a potential U.S. commercial launch of D-PLEX₁₀₀ in early 2027. The Company believes that its current cash position, together with its expected proceeds from its 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. Conference Call Dial-In & Webcast Information: About PolyPidPolyPid Ltd. (Nasdaq: PYPD) is an innovative biopharmaceutical company dedicated to elevating treatment effectiveness, right where care begins. The Company develops long-acting, controlled-release drugs designed to deliver therapy precisely at the site of care, addressing critical unmet medical needs across a wide and diverse pipeline spanning surgical care, metabolic diseases, and beyond. PolyPid’s lead product, D-PLEX₁₀₀, successfully met its primary and all key secondary endpoints in the landmark Phase 3 SHIELD II trial for the prevention of surgical site infections. Guided by a commitment to precision and innovation, PolyPid is redefining how therapies perform and raise the standard of patient care. For additional Company information, please visit http://www.polypid.com and follow us on Twitter (X) and LinkedIn. Forward-looking StatementsThis press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act and other securities laws. Words such as "expects," "anticipates," "intends," "plans," "believes," "seeks," "estimates" and similar expressions or variations of such words are intended to identify forward-looking statements. For example, the Company is using forward-looking statements when it discusses the anticipated timing of the FDA's review and potential approval of the D-PLEX₁₀₀ NDA, including the PDUFA goal date; the anticipated timing of the Company's planned MAA submission to the EMA for D-PLEX₁₀₀; the timing, receipt and amount of regulatory, launch and other milestone payments and royalties under the Company's agreement with Azurity; the potential label expansion of D-PLEX₁₀₀ and its funding by Azurity; the anticipated timing of a potential U.S. commercial launch of D-PLEX₁₀₀ by Azurity; the Company’s belief that it is potentially in the strongest financial position in the Company’s history, with no immediate financing needs ; the Company’s belief that its current cash position, together with its expected proceeds from its 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; the therapeutic and commercial potential of D-PLEX₁₀₀; and the Company's plans to advance Kynatrix™ technology through additional pipeline programs, including its long-acting metabolic program and additional infection opportunities beyond prevention. Forward-looking statements are not historical facts, and are based upon management's current expectations, beliefs and projections, many of which, by their nature, are inherently uncertain. Such expectations, beliefs and projections are expressed in good faith. However, there can be no assurance that management's expectations, beliefs and projections will be achieved, and actual results may differ materially from what is expressed in or indicated by the forward-looking statements. Forward-looking statements are subject to risks and uncertainties that could cause actual performance or results to differ materially from those expressed in the forward-looking statements. For a more detailed description of the risks and uncertainties affecting the Company, reference is made to the Company's reports filed from time to time with the Securities and Exchange Commission, including, but not limited to, the risks detailed in the Company's Annual Report on Form 20-F filed on February 25, 2026. Forward-looking statements speak only as of the date the statements are made. The Company assumes no obligation to update forward-looking statements to reflect actual results, subsequent events or circumstances, changes in assumptions or changes in other factors affecting forward-looking information except to the extent required by applicable securities laws. If the Company does update one or more forward-looking statements, no inference should be drawn that the Company will make additional updates with respect thereto or with respect to other forward-looking statements. References and links to websites have been provided as a convenience, and the information contained on such websites is not incorporated by reference into this press release. PolyPid is not responsible for the contents of third-party websites. Company Contact:PolyPid Ltd.Ori [email protected] Investor Relations Contact:Arx Investor RelationsNorth American Equities [email protected]

This article first appeared on GuruFocus. Net Loss: $7.8 million, or $0.35 per share, for Q2 2026, compared to a net loss of $10 million, or $0.78 per share, in Q2 2025. R&D Expenses: $6.1 million in Q2 2026, compared to $6.2 million in Q2 2025. G&A Expenses: $1.3 million in Q2 2026, compared to $2.5 million in the prior year period. Marketing and Business Development Expenses: $0.5 million in Q2 2026, compared to $0.7 million in Q2 2025. Cash Position: $6.6 million in cash and cash equivalents as of June 30, 2026, compared to $12.9 million in cash equivalents and short-term deposits at December 31, 2025. Upfront and Near-Term Milestone Payments: $30 million secured from the Azurity Pharmaceuticals commercialization partnership. Additional Milestone Payments: Over $290 million in potential regulatory, launch, and sales milestones. Royalties: Tiered royalties on Azurity sales in the U.S. and Canada, ranging from mid-teens to mid-20s percentages. Warning! GuruFocus has detected 3 Warning Sign with EYE. Is PYPD fairly valued? Test your thesis with our free DCF calculator. Release Date: August 12, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. FDA accepted the NDA for D-Plex 100 with priority review, setting a PDUFA goal date of November 28, 2026, ahead of schedule and with no filing review issues. Secured an exclusive commercialization partnership with Azurity Pharmaceuticals, including $30 million in upfront and near-term payments and over $290 million in potential milestones. The partnership includes tiered royalties (mid-teens to mid-20s percentages) and a transfer price on every manufactured unit, enhancing revenue potential. Azurity's existing commercial infrastructure, including relationships with over 1,700 hospitals and expertise in colorectal surgery, positions D-Plex 100 for a strong launch. The company expects existing cash resources, including partnership proceeds, to fund operations into 2028, with no immediate financing needs. The company reported a net loss of $7.8 million for Q2 2026, though improved from the prior year. Cash and cash equivalents decreased to $6.6 million as of June 30, 2026, from $12.9 million at the end of 2025, before the partnership payments. The FDA pre-approval inspection of the manufacturing facility remains a key risk, with no specific timeline communicated. The commercial launch of D-Plex 100 is dependent on FDA approval and successful manufacturing readiness, with potential delays. The company's reliance on Azurity for commercial execution in the U.S. and Canada introduces execution risk, and the partnership's long-term success is unproven. Q: What is the significance of the FDA's acceptance of the NDA for D-PLEX 100, and what are the key regulatory milestones ahead?A: Dikla Akselbrad, CEO, stated that the FDA accepted the NDA for filing ahead of schedule on July 27, 2026, with no filing review issues identified. The agency also granted Priority Review, setting a PDUFA goal date of November 28, 2026. This designation shortens the review period from 10 months to six months, reflecting the strength of the clinical package. The company is now preparing for the FDA pre-approval inspection of its manufacturing facility, with the expected commercial launch by partner Azurity in early 2027. Q: Can you provide details on the economic structure of the commercialization partnership with Azurity Pharmaceuticals?A: Dikla Akselbrad, CEO, detailed that the partnership includes a total of $30 million in secured upfront and near-term milestone payments, with eligibility for over $290 million in additional regulatory, launch, and sales milestones. PolyPid will also receive tiered royalties on U.S. and Canadian sales ranging from mid-teens to mid-20s percentages, plus an agreed transfer price on every unit manufactured and supplied. The deal also includes an Azurity-funded label expansion program, which the CEO described as exceptionally strong economics for a company at this stage. Q: Why was Azurity selected as the commercial partner, and what specific capabilities do they bring to the D-PLEX 100 launch?A: Ori Warshavsky, COO, explained that Azurity emerged from a highly competitive process due to their established credibility with infectious disease specialists, existing relationships with colorectal surgeons through their bowel prep products, and infrastructure reaching over 1,700 leading hospitals. With over 200 U.S. commercial-facing colleagues and a portfolio of 50+ medicines, Azurity brings the GPO infrastructure, hospital contracting expertise, and institutional relationships needed for a successful launch. Q: What is the company's financial position following the Azurity partnership, and how long will existing cash resources fund operations?A: Jonny Missulawin, CFO, reported that as of June 30, 2026, the company had $6.6 million in cash, subsequently strengthened by the $30 million in upfront and near-term payments from Azurity. The company expects existing cash resources, together with expected proceeds from the commercialization agreement, to fund operations into 2028 and through several significant upcoming milestones. The CFO emphasized there are no immediate financing needs in the near future. Q: What is the status of the European regulatory pathway for D-PLEX 100?A: Dikla Akselbrad, CEO, stated that during the second quarter, the company held productive meetings with the rapporteur and co-rapporteur designated to lead the assessment of the planned MAA. The company plans to submit the MAA to the European Medicines Agency in the third quarter of 2026 under the centralized procedure, which, if approved, would enable marketing across all EU member states. The CEO noted that no major issues were raised that would delay the submission timeframe. Q: What are the key performance indicators (KPIs) that will be used to track the success of the D-PLEX 100 launch?A: Dikla Akselbrad, CEO, and Ori Warshavsky, COO, outlined that KPIs will include monitoring hospital P&T committee approvals, the number of hospitals adding the drug to formulary, progress on NTAP reimbursement, and payer conversations. The stepwise approach will track month-by-month hospital adoption and physician usage, with the first 12 months from launch serving as the main benchmark for success. Q: When will revenue be recognized following the expected launch in early 2027?A: Dikla Akselbrad, CEO, confirmed that revenue will be recognized quite immediately upon launch because of the pre-negotiated transfer price per vial structure. Every vial sold to Azurity will generate revenue for PolyPid, with royalties and milestone payments recognized as they are earned. Q: How is the company preparing for the FDA pre-approval inspection, and what external validation has been received?A: Dikla Akselbrad, CEO, noted that the facility has passed four consecutive successful GMP inspections, including one by the Israeli Ministry of Health in September 2025. During the commercial evaluation process, prospective partners conducted on-site diligence at the Israeli site, providing external validation of manufacturing readiness. The team has also conducted multiple mock inspections with external consultants in preparation for the FDA inspection. Q: What are the initial label expansion efforts under the Azurity-funded joint development framework?A: Dikla Akselbrad, CEO, stated that the joint development framework is scoped around D-PLEX 100 for additional surgical site infection indications beyond the initial abdominal indication. The top target indications, consistent with Azurity's view, include cardiac procedures (specifically CABG), orthopedic procedures (hip and knee), and breast mastectomy and reconstruction. The final indication will depend on FDA discussions. Q: How does the earlier PDUFA date impact launch preparation and the NTAP submission process?A: Dikla Akselbrad, CEO, explained that the company prepared for both scenarios of approval timing, so the earlier PDUFA date does not change their plans. Ori Warshavsky, COO, added that the product does not need to be approved to submit for NTAPit only needs to be under FDA review. Azurity is working toward the October deadline to secure NTAP for the next governmental financial year. For the complete transcript of the earnings call, please refer to the full earnings call transcript.

Our analysts just identified a stock with the potential to be the next Nvidia. Tell us how you invest and we'll show you why it's our #1 pick. Tap here. Achieved a critical regulatory milestone with the FDA's formal acceptance of the D-PLEX100 NDA, which included a Priority Review designation and no identified filing review issues. Secured an exclusive commercialization partnership with Azurity Pharmaceuticals for the U.S. and Canada, selected for their established hospital infrastructure and existing relationships with colorectal surgeons. Structured the Azurity deal to capture multi-layered economics, including upfront payments, tiered royalties, and a guaranteed transfer price for manufacturing units retained by PolyPid. Maintained global manufacturing control as a strategic choice to maximize long-term product economics and leverage existing GMP-certified facilities in Israel. Advanced European market entry strategy through productive meetings with EMA Rapporteurs, confirming a planned MAA submission for the third quarter of 2026. Leveraged the Kynatrix technology platform to explore high-value treatment applications beyond prevention, utilizing the established safety and manufacturing foundation of D-PLEX100. Anticipates a PDUFA goal date of November 28, 2026, following the FDA's grant of Priority Review, which shortened the standard review period by four months. Targets a commercial launch of D-PLEX100 in the United States in early 2027, supported by Azurity's 200-person commercial-facing team and footprint in 1,700 hospitals. Plans to pursue label expansion into cardiac, orthopedic, and breast reconstruction surgeries through a joint development framework fully funded by Azurity. Projects that existing cash resources, bolstered by $30 million in recent milestone payments, will fund operations into 2028 and through key commercial milestones. Prepares for the upcoming FDA pre-approval inspection (PAI) of manufacturing facilities, utilizing mock audits and previous successful GMP inspections as a baseline. Strengthened the balance sheet with $30 million in aggregate payments following the Azurity signing and subsequent NDA acceptance. Reduced general and administrative expenses to $1.3 million, primarily due to lower non-cash expenses following the vesting of performance-based options. Maintained a streamlined capital structure with $7.3 million in outstanding warrants stapled to shares to ensure alignment with the long-term shareholder base. Confirmed that the Azurity partnership includes a funded pathway for label expansion, reducing PolyPid's incremental capital requirements for R&D. One stock. Nvidia-level potential. 30M+ investors trust Moby to find it first. Get the pick. Tap here. Management confirmed active communication with the FDA regarding audit schedules, noting the process is efficient due to the Priority Review timeline. Azurity and other bidders conducted on-site diligence in Israel to validate manufacturing readiness and commercial-scale capabilities prior to deal signing. Azurity already calls on colorectal surgeons for bowel prep products, providing immediate credibility and established institutional relationships. The launch will follow a stepwise approach, targeting 1,700 hospitals and academic centers through existing GPO infrastructure and expanded medical affairs teams. Revenue recognition will begin immediately upon launch in early 2027 via the pre-negotiated transfer price per vial supplied to Azurity. Key performance indicators will include the number of hospital P&T committee approvals, NTAP reimbursement progress, and specific minimums defined in the partnership agreement. Meetings with European Rapporteurs in June did not identify major issues or data gaps that would delay the planned Q3 2026 MAA submission. The submission will proceed under the Centralized Procedure to enable marketing across all EU member states upon potential approval.

Interested in PolyPid Ltd.? Here are five stocks we like better. FDA review advances: PolyPid’s NDA for D-PLEX100 was accepted on July 27, 2026, with priority review and a Nov. 28 PDUFA target date. The company is preparing for a pre-approval manufacturing inspection. Azurity partnership provides funding and commercialization support: The U.S. and Canada agreement includes $30 million in upfront and near-term milestone payments, more than $290 million in potential additional milestones, and tiered royalties. Azurity expects to launch D-PLEX100 in early 2027 if approved. Financial position improved: PolyPid’s second-quarter net loss narrowed to $7.8 million from $10 million a year earlier, while the subsequent Azurity payments strengthened liquidity and are expected to fund operations into 2028. PolyPid (NASDAQ:PYPD) said its second-quarter 2026 was marked by the FDA’s acceptance of its new drug application for D-PLEX100 and a commercialization agreement with Azurity Pharmaceuticals covering the United States and Canada. D-PLEX100 is being developed to prevent surgical site infections in patients undergoing abdominal corrective surgery. CEO Dikla Czaczkes Akselbrad said the FDA accepted the company’s NDA for filing on July 27, after the company completed its submission during the second quarter. The agency granted priority review and set a Prescription Drug User Fee Act goal date of Nov. 28, 2026. → SoundHound AI Sends a Loud Signal After Its Q2 Earnings Beat Akselbrad said the FDA identified no filing review issues in the acceptance notice. Priority review reduces the standard review timeline to six months from 10 months, according to the company. PolyPid expects an FDA pre-approval inspection of its manufacturing facility as part of the review process and continues to prepare for that inspection through mock audits and outside consultants. On July 17, PolyPid entered an exclusive agreement with Azurity Pharmaceuticals to commercialize D-PLEX100 in the U.S. and Canada. PolyPid said it has secured $30 million in aggregate upfront and near-term milestone payments, consisting of a $15 million payment at signing and a further $15 million payment following FDA acceptance of the NDA. → AST SpaceMobile Earnings Just Reminded Investors How Risky Space Can Be The agreement also provides PolyPid eligibility for more than $290 million in additional regulatory, launch and sales milestones. The company is entitled to tiered royalties on Azurity’s net sales ranging from the mid-teens to mid-20s percentages. PolyPid will retain global manufacturing responsibility and will receive an agreed transfer price for each unit supplied to Azurity. Chief Operating Officer Ori Warshavsky said Azurity was selected after a competitive partnering process involving multiple prospective commercial partners. He cited Azurity’s portfolio of more than 50 medicines, its hospital and surgical-channel presence, and relationships with more than 1,700 hospitals and academic institutions as factors supporting the selection. → First Solar’s Profit Engine Faces a New Policy Test in Washington Azurity will lead commercial activities including sales force development, national account planning, medical affairs and pharmacy-channel work. PolyPid will retain global regulatory strategy and manufacturing responsibilities. The companies have established joint forums for medical, regulatory and commercial launch preparations, management said. PolyPid expects Azurity to launch D-PLEX100 in the U.S. in early 2027, assuming regulatory approval. Management said the commercial rollout is expected to proceed hospital by hospital and integrated delivery network by integrated delivery network rather than reaching all target institutions immediately. The company said its manufacturing site in Israel has passed four consecutive good manufacturing practice inspections, including an inspection by Israel’s Ministry of Health in September 2025. Prospective commercial partners, including Azurity, also conducted on-site diligence of the facility during the partnering process, management said. In response to analyst questions, Akselbrad said PolyPid has had several communications with the FDA since filing the NDA, including discussions relating to expected audits, but did not provide a specific date for the agency’s pre-approval inspection. Management said commercial launch metrics will include hospital adoption, pharmacy and therapeutics committee approvals, pilot usage by physicians, reimbursement progress and discussions with payers. If D-PLEX100 launches in early 2027, PolyPid expects to recognize revenue as it supplies vials to Azurity under the agreed transfer price, while royalty and milestone revenue would be recognized as applicable. Warshavsky said Azurity is pursuing a New Technology Add-on Payment, or NTAP, application for the next government fiscal year. He said FDA approval is not required before submitting an NTAP application, provided the product is under FDA review, and noted an October deadline. PolyPid also plans to submit a marketing authorization application to the European Medicines Agency during the third quarter of 2026. Akselbrad said the company held meetings during the quarter with the EMA rapporteur and co-rapporteur and characterized them as productive. She said the discussions did not identify issues requiring additional data or changes that would delay the planned submission timeline. The Azurity agreement includes an Azurity-funded joint development framework intended to pursue label expansion opportunities beyond the initial abdominal surgery indication. Management identified cardiac procedures, including coronary artery bypass grafting, orthopedic procedures such as hip and knee replacement, and breast mastectomy and reconstruction as potential areas of interest. PolyPid also cited expansion into territories outside the U.S. and Canada and further development of its PLEX technology platform as longer-term growth drivers. Warshavsky said the company is exploring applications beyond infection prevention, including treatment applications and a long-acting metabolic program, but did not provide specific product details or development timelines. Research and development expense was $6.1 million in the second quarter, compared with $6.2 million a year earlier. General and administrative expense fell to $1.3 million from $2.5 million, primarily due to lower non-cash expenses related to performance-based options. Marketing and business development expense was $0.5 million, compared with $0.7 million in the prior-year period. Net loss totaled $7.8 million, or $0.35 per share, compared with a 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 with $18.2 million in the prior-year period. As of June 30, PolyPid had $6.6 million in cash and cash equivalents, compared with $12.9 million in cash equivalents and short-term deposits at Dec. 31, 2025. CFO Jonny Missulawin said the subsequent $30 million in Azurity payments strengthened the company’s capital position. Based on current plans and assumptions, PolyPid expects available resources, partnership proceeds and potential future proceeds to fund operations into 2028. PolyPid 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. This instant news alert was generated by narrative science technology and financial data from MarketBeat in order to provide readers with the fastest reporting and unbiased coverage. Please send any questions or comments about this story to [email protected]. The article "PolyPid Q2 Earnings Call Highlights" was originally published by MarketBeat. View MarketBeat's top stocks for August 2026.

Interested in PolyPid Ltd.? Here are five stocks we like better. PolyPid said it has entered a key regulatory transition for D-PLEX100, with its rolling NDA submission to the FDA underway and the remaining clinical module expected to be filed imminently. The company also plans to seek a European MAA in Q3 2026. Management said U.S. partnership talks are in late stages, as PolyPid looks for a hospital-focused partner to support a commercial launch targeted for Q1 2027. The company is also building commercial readiness through conferences, publications, and clinician engagement. PolyPid reported a narrower Q1 net loss of $7.7 million versus $8.3 million a year earlier, with $10.9 million in cash at quarter-end. Management said current cash should fund operations into the second half of 2026, and the company has since repaid its remaining loan facility. PolyPid (NASDAQ:PYPD) said its first quarter marked a transition from late-stage clinical development toward regulatory submission and commercial preparation for D-PLEX100, its lead product candidate for preventing surgical site infections in abdominal colorectal surgery. Chief Executive Officer Dikla Czaczkes Akselbrad told investors that the company’s priorities are advancing D-PLEX100 toward potential U.S. Food and Drug Administration approval and finalizing a U.S. strategic partnership intended to support a commercial launch in the first quarter of 2027. → Rocket Lab Just Hit a New All-Time High—Time to Buy or Let It Breathe? “The first quarter of 2026 was a defining transition for PolyPid,” Czaczkes Akselbrad said. “We moved from late-stage clinical development to final NDA regulatory submission.” PolyPid initiated its rolling new drug application submission to the FDA on March 30, 2026. Czaczkes Akselbrad said the company has submitted the chemistry, manufacturing and controls module, non-clinical modules and administrative components. The remaining components, including the clinical module, are expected to be submitted “imminently,” which would complete the full NDA submission. → MercadoLibre Boldly Invests in Growth: Discount Deepens D-PLEX100 has received Fast Track and Breakthrough Therapy designations, making it eligible for priority review if the FDA accepts the application and grants that status. Czaczkes Akselbrad said priority review would shorten the standard review period from 10 months to six months. The company also received a small business waiver from the FDA in March for the Prescription Drug User Fee Act fee, which Czaczkes Akselbrad said was approximately $4.3 million. She said the waiver allows PolyPid to direct resources toward commercialization preparation as it moves closer to potential approval. → MP Materials Is Quietly Building a Rare Earth Powerhouse In Europe, the company has scheduled meetings this quarter with the rapporteur and co-rapporteur for its planned Marketing Authorisation Application. PolyPid plans to submit the MAA under the European Medicines Agency’s centralized procedure, which would allow a single application covering all European Union member states if approved. Subject to the outcome of the meetings, the company currently plans to submit the MAA in the third quarter of 2026. Czaczkes Akselbrad said discussions with potential U.S. strategic partners have progressed into what the company believes are late stages, with due diligence and evaluation work “well behind” the company and the process now focused on negotiating definitive agreement terms. During the question-and-answer portion of the call, Czaczkes Akselbrad said the company’s priorities for a partnership have not shifted. She said PolyPid continues to seek a partner with “good presence in the hospital” and the ability to build and expand a hospital-focused sales force. Ori Warshavsky, PolyPid’s chief operating officer for the U.S., said the company is also continuing broader commercial readiness work, including conference engagement, planned scientific publications and discussions with clinical leaders. He said PolyPid hosted a roundtable with key opinion leaders at the Surgical Infection Society annual meeting earlier this month. Warshavsky also pointed to U.S. hospital trends that he said may be relevant for D-PLEX100, including greater focus on infection prevention, antimicrobial stewardship and reducing systemic antibiotic use. He also discussed Medicare’s Transforming Episode Accountability Model, or TEAM, which he said makes hospitals financially accountable for certain complications occurring within 30 days after selected surgical procedures, including colorectal surgery. “We believe D-PLEX100 is well-aligned with both trends,” Warshavsky said, citing the product candidate’s design to deliver antibiotic protection locally at the surgical site for approximately 30 days. PolyPid also discussed recent scientific presentations tied to its SHIELD II Phase 3 results. Czaczkes Akselbrad said the company presented an analysis of ASEPSIS score data at the Surgical Infection Society annual meeting in early May, showing a 64% relative risk reduction in patients with an ASEPSIS score greater than 20, the threshold for clinically significant wound infection. Warshavsky said the finding has potential commercial implications because fewer severe wound events could translate into reduced wound complications, less reliance on intravenous antibiotics, possible earlier hospital discharge and lower hospital resource use. He said those themes are central to the company’s health economics work. In April, PolyPid presented pharmacokinetic data at the European Society of Clinical Microbiology and Infectious Diseases. Czaczkes Akselbrad said the data provided further evidence that D-PLEX100 delivers sustained, controlled release of doxycycline for approximately 30 days. On manufacturing, Czaczkes Akselbrad said an FDA inspection of the company’s manufacturing facility is expected after the NDA is accepted. She said PolyPid is working with external consultants, including experienced quality professionals with FDA inspection experience, and has conducted multiple mock inspections. In response to an analyst question about inspection readiness, Czaczkes Akselbrad emphasized that PolyPid owns its manufacturing facility rather than relying on a contract manufacturer. She said mock inspections produced comments and suggestions, but “nothing that we viewed as major.” She also noted that the facility has passed four consecutive GMP inspections, including the most recent one by the Israeli Ministry of Health. Chief Financial Officer Jonny Missulawin reported that research and development expenses were $5.8 million for the first quarter of 2026, compared with $6.1 million in the prior-year period. He said the decline primarily reflected completion of the SHIELD II Phase 3 trial and the transition toward regulatory submission and commercial readiness activities. General and administrative expenses were $1.6 million, compared with $1.2 million a year earlier. Marketing and business development expenses were $0.4 million, compared with $0.3 million in the first quarter of 2025. PolyPid reported a first-quarter net loss of $7.7 million, or $0.35 per share, compared with a net loss of $8.3 million, or $0.70 per share, in the same period last year. As of March 31, 2026, PolyPid had $10.9 million in cash equivalents and short-term deposits, down from $12.9 million at the end of 2025. Missulawin said the decrease reflected operating activities, partially offset by proceeds from warrant exercises. After the quarter ended, PolyPid completed repayment of its remaining loan facility, originally entered into in April 2022. Missulawin said the company has no remaining loan-related liabilities as of the date of the earnings release. Based on current plans and assumptions, he said existing cash resources are expected to fund operations into the second half of 2026 and through several potential milestones. In response to analyst questions, Czaczkes Akselbrad said PolyPid expects to conduct some pre-launch activities itself, including work around packaging, naming, scientific conferences and publication of SHIELD II data in a peer-reviewed journal. She said the company does not expect to market D-PLEX100 on its own. She also outlined three possible paths for the company’s pipeline: expanding D-PLEX beyond abdominal surgery, expanding the PLEX platform into other indications and advancing a younger program in metabolic health. Czaczkes Akselbrad said the company envisions multiple products, some late-stage and some earlier-stage. Closing the call, Czaczkes Akselbrad said the rolling NDA submission, late-stage U.S. partnership discussions, European regulatory plans and strengthened balance sheet represent “the most consequential phase” in PolyPid’s history. PolyPid 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. This instant news alert was generated by narrative science technology and financial data from MarketBeat in order to provide readers with the fastest reporting and unbiased coverage. Please send any questions or comments about this story to [email protected]. The article "PolyPid Q1 Earnings Call Highlights" was originally published by MarketBeat. View MarketBeat's top stocks for May 2026.

Our analysts just identified a stock with the potential to be the next Nvidia. Tell us how you invest and we'll show you why it's our #1 pick. Tap here. Initiated a rolling NDA submission for D-PLEX100 in abdominal colorectal surgery, completing CMC and nonclinical modules with clinical components expected imminently. Advanced U.S. commercial partnership discussions to late-stage negotiations, shifting focus from due diligence to finalizing definitive agreement terms. Strengthened the clinical value proposition with new SHIELD II data showing a 64% relative risk reduction in clinically significant wound infection severity. Positioned D-PLEX100 to align with Medicare's new TEAM reimbursement model, which holds hospitals financially accountable for complications within a 30-day post-surgery window. Leveraged Breakthrough Therapy Designation to maintain frequent communication with the FDA regarding CMC processes and development reports prior to formal submission. Maintained operational continuity and manufacturing readiness despite regional conflict, noting that the FDA has recently inspected other Israeli facilities. Anticipates a potential 6-month priority review period if granted by the FDA, which would shorten the standard 10-month review timeline. Plans to submit a Marketing Authorization Application (MAA) to the EMA in Q3 2026 following alignment meetings with European regulators. Targets a formal U.S. commercial launch in the first quarter of 2027, supported by a strategic partner with established hospital sales infrastructure. Expects current cash resources to fund operations into the second half of 2026, covering several significant upcoming milestones. Prepares for a critical FDA pre-approval inspection of the internal manufacturing facility, supported by multiple successful mock audits and external consultants. Received a $4.3 million PDUFA fee waiver from the FDA under small business provisions, preserving capital for commercialization activities. Achieved a debt-free balance sheet following the full repayment of the remaining 2022 loan facility in early May 2026. Reported a narrowed net loss of $7.7 million for Q1 2026, down from $8.3 million in the prior year period, reflecting the completion of Phase III trials. One stock. Nvidia-level potential. 30M+ investors trust Moby to find it first. Get the pick. Tap here. Management emphasized that owning their manufacturing facility provides full control over QA and processes, unlike relying on a CMO. Mock inspections identified only minor comments that have already been addressed or are currently being implemented. The company utilized Breakthrough Therapy status to align with the FDA on risky CMC aspects well before the actual filing. Management noted that the FDA inspected two other Israeli facilities as recently as March 2026. The company does not expect the conflict to delay approval, citing the FDA's ability to use alternative inspection means as demonstrated during COVID-19. PolyPid will continue leading scientific and clinical awareness activities, including peer-reviewed publications, while the partner handles direct sales. Future strategy involves expanding D-PLEX100 into other surgical indications and advancing earlier-stage programs in metabolic health.

Image source: The Motley Fool. Wednesday, May 13, 2026 at 8:30 a.m. ET Chief Executive Officer — Dikla Czaczkes Akselbrad Chief Financial Officer — Jonny Missulawin Chief Operating Officer, U.S. — Ori Warshavsky Head of Investor Relations — Yehuda Leibler Need a quote from a Motley Fool analyst? Email [email protected] Yehuda Leibler: Thank you, operator, and thank you all for joining PolyPid's First 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 3 months ended March 31, 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 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 discussing the company's regulatory strategy, including the expected completion of the rolling New Drug Application or NDA submission for D-PLEX100. Management may also discuss the company's planned engagements with the European Medicines Agency, or EMA, including meetings with the Rapporteur and Co-Rapporteur regarding the planned marketing authorization application, or MAA, and the anticipated timing thereof. In addition, management may discuss the company's ongoing U.S. commercial strategic partnership discussions, its belief that those discussions are in late stages and expected launch plans and timing. Other forward-looking statements may relate to the potential clinical and economic value proposition of D-PLEX100. The company's preparations for potential commercialization, the potential for 2026 to be a transformative year for PolyPid and the expectation that current cash resources will be sufficient to fund operations into the second half of 2026 and from 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, May 13, 2026. With that, it is my pleasure to turn the call over to Dikla Akselbrad, the CEO of PolyPid. Dikla? Dikla Akselbrad: Thank you, Yehuda, and thank you all for joining us today. The first quarter of 2026 was a defining transition for PolyPid. We moved from late-stage clinical development to final NDA regulatory submission, our U.S. commercial strategic partnership discussion advanced to what we believe are their late stages, and we continue to build the foundation for what we expect will be a transformative year. Our focus remains on two priorities: advancing D-PLEX100 towards potential FDA approval and finalizing a U.S. strategic partnership that will execute commercial launch in the first quarter of 2027. Starting with our regulatory progress. On March 30, 2026, we initiated our NDA submission to the FDA. As a reminder, D-PLEX100 is our lead product candidate for the prevention of surgical site infections, or SSI, in patients undergoing abdominal colorectal surgery. With this initial filing, we submitted the CMC and nonclinical modules as well as other more administrative modules. We expect to submit the remaining components, including the clinical module imminently. This will complete the full NDA submission. Once the FDA accepts our submission and given our Fast Track and breakthrough therapy designation, the product is eligible for priority review. If received, this would shorten the standard review period from 10 months to 6 months. In parallel, in March 2026, we received a small business waiver from the FDA for the PDUFA fee. This waiver was approximately $4.3 million, and it allows us to focus our resources on commercialization preparation as we move closer to potential approval. Turning to Europe. We have scheduled meetings in this quarter with the Rapporteur and Co-Rapporteur, which are the European regulatory authorities designated to lead the assessment of our planned MAA for D-PLEX100. The purpose of these meetings is to align on the content and structure of the submission. Importantly, the MAA will be submitted to the EMA under the centralized procedure on the basis of the therapeutic innovation. The centralized procedures allows the submission of a single marketing application to the EMA that, if approved, enables the product to be marketed in all EU member states. Subject to the outcome of these meetings, we currently plan to submit the MAA in the third quarter of this year. On the commercial front, our strategic partnership discussions with potential U.S. partner have continued to progress. We believe they are now in their late stages as the due diligence and evaluation work that defined earlier phases of this discussion is well behind us, and we are currently focused on the active negotiation of definitive agreement terms. Another important area of commercial readiness is our manufacturing and inspection preparations. Once the FDA accepts our NDA submission, the agency is expected to inspect our manufacturing facility. This is a critical step on the path to potential approval, and we are devoting significant resources to these preparations. We are working closely with experienced external consultants, including industry quality veterans with robust FDA experience who provide us with valuable guidance regarding FDA expectations. We have also conducted multiple mock inspections to ensure our site is ready, the team is prepared and the FDA inspection passes without any major issues. As a reminder, our facility has already passed four consecutive successful GMP inspections, including the most recent one by the Israeli Ministry of Health. We are entering the FDA inspection process from a position of strength, and we are highly focused on getting it right for first time. We have also continued to advance our engagement with the scientific community surrounding the SHIELD II phase III results with two important data presentations this quarter. In early May 2026, at the 45th Annual Meeting of the Surgical Infection Society, we presented an analysis of SHIELD II Asepsis score data, a clinical measure of wound infection severity. The results showed a 64% relative risk reduction in patients with an asepsis score greater than 20, which is the threshold for clinically significant wound infection. What this tells us is that even among patients in the D-PLEX arm who did experience wound events, severity was meaningfully reduced. Ori will speak in a moment to what this potentially means commercially. In April 2026, at the European Society of Clinical Microbiology and Infectious Diseases, also known as ESCMID, we presented new pharmacokinetic or PK data providing further evidence that D-PLEX100 delivers sustained controlled release of doxycycline for approximately 30 days. This result in our largest human data set to date support the core mechanistic premise of our technology. With that, I will now turn the call over to Ori Warshavsky, our Chief Operating Officer, U.S. Ori? Ori Warshavsky: Thank you, Dikla. I would like to spend a few minutes on the broader commercial readiness work underway. Alongside the partnership process and manufacturing readiness, we are continuing with our commercial readiness activities across several other fronts. Picking up on the asepsis data Dikla just referenced, those results have meaningful potential commercial implications. A 64% relative risk reduction with a P value of 0.0103 in severe wound events translates directly to fewer wound complications, less reliance on intravenous antibiotics, the potential for earlier hospital discharge and lower hospital resource utilization. That is exactly the language hospital P&T committees and payers respond to, and we believe that this is central to the health economics work we are now accelerating. Alongside this, we are expanding our presence at major surgical and infectious disease conferences, advancing additional planned scientific publications and continuing to engage leading clinical voices in the field. As part of these efforts, we hosted a roundtable discussion with KOLs earlier this month at the Surgical Infection Society annual meeting, which was chaired by the president of the society. There were a lot of good insights during that meeting, including an open discussion on the fact that infection rates are often underreported to avoid penalties and that growing obesity rates are impacting infection rates in abdominal surgeries. At the general assembly of the conference, there was a call from the stage to see how the society can, and I quote, "Help move practice forward with a really novel product." Together, these efforts build the awareness and the evidence base that will support a successful launch. I would also like to briefly address the broader environment in which D-PLEX100 would be launched. Two converging trends are shaping that environment in important ways. The first is the growing focus across U.S. hospital systems on infection prevention, antimicrobial stewardship and reducing the use of systemic antibiotics. The second is the evolving reimbursement landscape. Under Medicare's new Transforming Episode Accountability model known as TEAM, hospitals are now financially accountable for inpatient and outpatient complications occurring throughout the 30 days following certain surgical procedures, including colorectal surgery. This represents a significant shift as the 30-day window for SSI is no longer just a clinical concern, it is increasingly tied to how hospitals are reimbursed. We believe D-PLEX100 is well-aligned with both trends. By delivering high concentration of broad-spectrum antibiotic directly at the surgical site rather than relying on systemic antibiotic load, D-PLEX100 supports the same antimicrobial stewardship goals hospital systems are increasingly being asked to advance. Just as important, D-PLEX100 is designed to provide antibiotic protection for approximately 30 days, the same window which hospitals are now financially accountable for. We expect this convergence, clinical data on one side, policy-driven economic incentives on the other to be an increasingly important part of D-PLEX's position with hospital system and payers as we move towards potential commercialization. With that, I will now turn the call over to Jonny to review our financial performance for the quarter. Jonny? Jonny Missulawin: Thank you, Ori. I will now walk through our financial results for the first quarter ended March 31, 2026. Starting with operating expenses, research and development expenses for the first quarter of 2026 were $5.8 million compared to $6.1 million in the first quarter of 2025. This decrease primarily reflects the completion of the SHIELD II phase III trial and our ongoing transition towards regulatory submission and commercial readiness activities. General and administrative expenses for the quarter were $1.6 million compared to $1.2 million for the same period in 2025. Marketing and business development expenses were $0.4 million compared to $0.3 million in the prior year period. Net loss for the first quarter of 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 the first quarter of 2025. Turning to the balance sheet, as of March 31, 2026, PolyPI'd had $10.9 million in cash -- cash equivalents and short-term deposits compared to $12.9 million on December 31, 2025. The modest decrease approximately $2 million reflects continued operating activities, partially offset by proceeds from warrant exercises during the quarter. Subsequent to quarter end, our balance sheet has been further strengthened by an additional development. In early May 2026, we completed the full repayment of our remaining loan facility originally entered into in April 2022. As a result, the company has fully repaid its outstanding debt obligations and has no remaining loan-related liabilities as of the date of today's earnings release, further strengthening our balance sheet ahead of potential commercialization. Based on our current plans and assumptions, we believe that our existing cash resources will be sufficient to fund operations into the second half of 2026 and through several significant upcoming potential milestones. With that, we will now open the call for questions. Operator? Operator: [Operator Instructions] We will take our first question and the first question comes from the line of Chase Knickerbocker from Craig-Hallum. Chase Knickerbocker: Maybe just to start, a couple on the filing. Just as we kind of think about that CMC module, maybe talk about the work that you've done with consultants internally to kind of submit that module with confidence, I think, particularly around kind of the process validation portions with your differentiated drug product, which obviously also comes with some novel aspects being that it is differentiated, right? So maybe just speak to kind of the work you've done with consultants and the confidence you've kind of gained there. And then secondly, I'll just ask both upfront. As you think about kind of the inspection readiness, you had several mock audits at this point. Maybe just talk to us a little bit about how those have progressed, how your findings from those have progressed and again, kind of increase your confidence in the positioning of your filing. Dikla Akselbrad: Thank you, Chase. So I'll start with the first portion on the CMC. Obviously, there is the aspect of consultants and regulatory consultant. But I think the most reassuring portion here is that we took advantage of -- or we used the Breakthrough Therapy Designation, which allows us to have more frequent communication with the FDA. And we really communicate prior to submission the NDA with the FDA on different processes on different methods as well as submitting the development report and everything that we thought could be risky, and we wanted the agency feedback ahead of submitting an NDA, we did that. So yes, there is a portion of getting advised and reviews, and we have a very experienced team in the CMC aspect from the development stage up to the actual operational aspect. But we also used -- communicate with the FDA multiple times to make sure that we are aligned with what they are expecting to see. So that's on the module -- the CMC module. On the preparation for the inspection, there are a couple of things that I think we've done from the start. The first one being the fact that we have built our own manufacturing facility. So it's not a CMO. We have full control of the processes on the method, regulation, all the implementation methods internally, both in terms of our employees as well as our QA. It's all internal. And that's, I think, a good thing and strengthen our position. The other thing is really working from day one with the eyes to the FDA expectation, always staying up to date to see what is the FDA expectation, what is the most recent expectation -- and this is why we were able to pass this inspection, which are also, by the way, qualified for the European authorities. So that's an ongoing. And now as we get closer to the pre-approval inspection, obviously, we are even tightening those processes, even tightening what is needed, working with very veteran quality person that really been on almost on a weekly basis part of FDA inspection, so we could really know what the FDA is focusing on these days. Now you were asking about specifically if anything came out of this mock inspection that can put this in danger. I'm very freely, I can say that we don't think so that obviously, there is -- when there is an inspection, there are comments, there are suggestions, there are reviews, but all of it is things that either have already been implemented and corrected or things that are ongoing, but nothing that we viewed as major. And also the -- for the matter of the Israeli Ministry of Health did not see those as major or critical. Operator: Your next question comes from Jason Butler from Citizens JMP. Jason Butler: First one for me. Just can you speak to any dialogue that you've had with FDA since submitting the first modules of the NDA? Have you had any questions or information requests from FDA yet? Dikla Akselbrad: So as we showed previously -- again. So not something formal, nothing formal at this stage, but we've not completed the NDA submission. So we don't really expect to get anything. But the NDA submission is -- or the completion is expected imminently. So I'm sure we'll start to get that immediately after. Jason Butler: Great. And then you've spoken in the past about what you're looking for from a commercial partnership or collaboration. Can you just speak to -- as you continue those discussions, have those priorities shifted at all? Or are your goals the same out of any partnership? Dikla Akselbrad: So no, they have not shifted. We are still focused and we think that the main objective is to have a partner with good presence in the hospital and capabilities to build and expand on a sales force that is in the hospital. That's what we are looking at. And we're very pleased so far. Operator: Your next question comes from the line of Boobalan Pachaiyappan from ROTH Capital Partners. Boobalan Pachaiyappan: A couple from us. Maybe to start with, I was wondering if you could talk about the tariff rate for drugs that are manufactured in Israel and commercialized in the U.S. and other countries. Is it like a flat tariff rate regardless of indications? Any color on that, please? Dikla Akselbrad: Ori, do you want to take this one regarding the U.S.? Ori Warshavsky: Yes. So the question -- just so I understand the question is regarding tariffs on products from Israel to the U.S. Boobalan Pachaiyappan: Yes, for drug products that are manufactured in Israel and commercialized in the U.S. and other countries. Ori Warshavsky: That's a good question. As far as I know, and we can follow up on this later, there's a flat tariff rate be negotiated between the government of the U.S. and Israel on all incoming goods coming from Israel to the U.S. We can follow up on this with the rates. Boobalan Pachaiyappan: All right. That's helpful. And in light of the ongoing conflict in the Middle East area region, can you maybe talk about the time line or the impact of this conflict on the inspection procedure to be conducted by the FDA? How are you thinking about it? And if you expect the inspection time line to be sort of -- is there -- at what point do you think you will have more clarity on whether or not the inspection will take place in second half of '26? Dikla Akselbrad: So thank you for this question, Boobalan. Obviously, if we knew this answer, we would have been -- we could use it in many, many other aspects. But seriously, we know that the FDA was inspecting two facilities in Israel this last March. Obviously, since March, they were not here. We do not expect this to have an effect. The FDA has many means to inspect the facility, either from -- COVID was here 2 years almost and drugs were approved. So I think both companies and the agency find ways to get drugs approved. So we do not expect it to change anything. We are operating in a normal course of business. You can see both in terms of the time line, we were committed to submitting the NDA before the end of the first quarter, which was done. We are now very shortly, we'll finalize this submission. And the team here is fully committed to all of these processes. And on a personal note, I hope that it will come and there won't be any issues. Boobalan Pachaiyappan: All right. Maybe one last one. I understand D-PLEX100 will be commercialized by the strategic partner. So just curious, I mean, do you still need to hire some employees to sort of internally track the progress? And can you also talk about the impact of this on G&A spend? Dikla Akselbrad: So I'll let Jonny add on that. But specifically on G&A, I don't see any major impact. We do think that there will be some increase later on as we expand the commercialization and sales increase, we'll need more employees on the operational front, obviously. And once we can discuss more clearly on next step, we will also lay out the development plan as we see it. Jonny Missulawin: No, I agree. So for the whole G&A part, we wouldn't expect such a big increase, but there will be some increase. And as Dikla said, the bigger increase will be in the operational part. Operator: [Operator Instructions] We will take our next question, and the question comes from Brandon Folkes from H.C. Wainwright. Brandon Folkes: Congrats on the progress. Maybe just two for me. Can you talk about how broad of a development pipeline you would consider once you do execute on a commercial transaction? Are you envisioning a singular product development focus going forward? Or could we sort of see a pretty broad pipeline? And then secondly, you remain very disciplined on the SG&A line. So can you just talk about if you envision PolyPid itself doing any market awareness this year ahead of an approval and ahead of a potential partnership? Dikla Akselbrad: Thank you. Thank you, Brandon. So I'll start with the first portion of your question. In terms of -- or maybe let's start with the latter. We do see PolyPid doing some prelaunch activities. Everything that was done up until now was done by us, whether it is around packaging names, scientific conference, all of that is done with us, and we'll see some of it also continues. We are hoping to publish the manuscript of the SHIELD I -- the SHIELD II data in a peer-reviewed journal soon. All of this is the more scientific clinical assets are managed by us and we'll be able to again say more how much of it will be managed by us or the partner. On other geographies, it's to be seen depending on the arrangement that we will get to. But generally, for D-PLEX, we do not see ourselves marketing the product on our own. In terms of our pipeline, this is a very important question. We envision the pipeline, and this is work that is done already and some of those are communicated to investors, but I think once we have a partner that could be even further reassessed and strengthened, we envision three paths. One is obviously -- and this was discussed quite intensively expanding D-PLEX behind abdominal indication. There is a high need in many other surgeries, and this will be done with the partner. The other is expanding our PLEX platform to other indications. And we also have our younger program in the metabolic health. So I envision and we envision multiple products that some are late stage and some are more early stage. Operator: There seems to be no further questions. I will now hand the call back to Dikla for closing remarks. Dikla Akselbrad: Thank you all for joining us today. The first quarter of 2026 marked a critical transition for PolyPid. Our rolling NDA submission is well underway with completion expected imminently. Our U.S. strategic partnership discussions are in their late stages. Our European regulatory strategy is advancing toward an MAA submission later this year, and our balance sheet has been meaningfully strengthened. Together, these milestones mark what we believe is the most consequential phase in our company's history. We continue to believe that 2026 has the potential to be a transformative year for PolyPid, and we look forward to providing further updates as these milestones unfold. Thank you. Operator, you may now close the call. Operator: This concludes today's conference call. Thank you for participating. You may now disconnect. Before you buy stock in PolyPid, consider this: The Motley Fool Stock Advisor analyst team just identified what they believe are the 10 best stocks for investors to buy now… and PolyPid wasn’t one of them. The 10 stocks that made the cut could produce monster returns in the coming years. 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As with all our articles, The Motley Fool does not assume any responsibility for your use of this content, and we strongly encourage you to do your own research, including listening to the call yourself and reading the company's SEC filings. Please see our Terms and Conditions for additional details, including our Obligatory Capitalized Disclaimers of Liability. The Motley Fool has no position in any of the stocks mentioned. The Motley Fool has a disclosure policy. PolyPid (PYPD) Q1 2026 Earnings Transcript was originally published by The Motley Fool

This article first appeared on GuruFocus. Release Date: May 13, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. PolyPid Ltd (NASDAQ:PYPD) has initiated the NDA submission for DPLEX-100 to the FDA, with the expectation of completing it imminently. The company received a small business waiver from the FDA for the PDUFA fee, saving approximately $4.3 million. Strategic partnership discussions in the U.S. are in late stages, focusing on definitive agreement terms. PolyPid Ltd (NASDAQ:PYPD) has conducted multiple mock inspections to prepare for FDA inspection, with no major issues identified. The company has fully repaid its outstanding debt obligations, strengthening its balance sheet ahead of potential commercialization. PolyPid Ltd (NASDAQ:PYPD) reported a net loss of $7.7 million for Q1 2026, although this is an improvement from the previous year. General and administrative expenses increased to $1.6 million from $1.2 million in the same period last year. The company's cash reserves decreased from $12.9 million to $10.9 million as of March 31, 2026. There is uncertainty regarding the timeline for FDA inspection due to potential geopolitical issues in the Middle East. The company anticipates some increase in operational expenses as commercialization efforts expand. Warning! GuruFocus has detected 2 Warning Signs with KRNT. Is PYPD fairly valued? Test your thesis with our free DCF calculator. Q: Can you discuss the work done with consultants to submit the CMC module with confidence, particularly around process validation for your differentiated drug product? A: We utilized the breakthrough therapy designation for frequent communication with the FDA, ensuring alignment on expectations. We also engaged experienced teams and regulatory consultants to review and advise on the CMC aspects. Our own manufacturing facility gives us full control over processes, which strengthens our position. Mock inspections have been conducted, and no major issues were identified. (CEO) Q: Have you had any dialogue with the FDA since submitting the first modules of the NDA? A: No formal communication has occurred yet, as the NDA submission is not complete. We expect to receive feedback once the submission is finalized imminently. (CEO) Q: Have your priorities shifted in your commercial partnership discussions? A: Our priorities remain the same. We are focused on finding a partner with a strong hospital presence and the capability to expand a sales force within hospitals. (CEO) Q: What is the tariff rate for drugs manufactured in Israel and commercialized in the U.S.? A: There is a flat tariff rate pre-negotiated between the U.S. and Israel for all incoming goods. We can follow up with specific rates. (COO) Q: How might the ongoing Middle East conflict impact the FDA inspection timeline? A: We do not expect the conflict to affect the inspection timeline. The FDA has various means to conduct inspections, as seen during the COVID-19 pandemic. We are operating as usual and committed to our timelines. (CEO) For the complete transcript of the earnings call, please refer to the full earnings call transcript.

Initiated NDA Submission to the FDA for D-PLEX₁₀₀ ; Completion Expected Imminently U.S. Commercial Partnership Discussions in Late Stages Conference Call Scheduled for Today at 8:30 AM ET PETACH TIKVA, Israel, May 13, 2026 (GLOBE NEWSWIRE) -- PolyPid Ltd. (Nasdaq: PYPD) (“PolyPid” or the “Company”), an innovative biopharmaceutical company dedicated to improving patient outcomes by elevating treatment effectiveness, right where care begins, today provided a corporate update and reported financial results for the three months ended March 31, 2026. Recent Corporate Highlights: Initiated NDA Submission to the FDA under Rolling Review: On March 30, 2026, the Company initiated a New Drug Application ("NDA") submission to the U.S. Food and Drug Administration ("FDA") for D-PLEX₁₀₀, the Company's lead product candidate for the prevention of surgical site infections ("SSIs") in patients undergoing colorectal surgery. The first modules, including the Chemistry, Manufacturing and Controls ("CMC") and nonclinical sections, were submitted as part of the rolling review, with additional components, including the clinical section, expected to be submitted imminently, marking the completion of the NDA submission. In March 2026, the FDA granted PolyPid a small business waiver of the Prescription Drug User Fee Act ("PDUFA") fee of approximately $4.3 million for the D-PLEX₁₀₀ NDA. This meaningful waiver enables the Company to focus its resources on commercialization preparations. Advancing EU Regulatory Submission: The Company has scheduled meetings in the second quarter of 2026 with the European Medicines Agency (“EMA”) Rapporteur and Co-Rapporteur, which are European regulatory authorities designated to lead the assessment of the planned Marketing Authorization Application ("MAA") for D-PLEX₁₀₀, to align on the content and structure of the planned submission. The MAA, which will be submitted to the EMA under the Centralized Procedure on the basis of therapeutic innovation, is currently planned for the third quarter of 2026. U.S. Commercial Partnership Discussions in Late Stages: The Company's strategic partnership discussions with potential U.S. commercial partner for D-PLEX₁₀₀ have continued to progress and are now in what the Company believes are its late stages. New SHIELD II Phase 3 Data Presented at Two Medical Congresses: At the 45th Annual Meeting of the Surgical Infection Society (SIS) in May 2026, an analysis of ASEPSIS1 score data showed a 64% relative risk reduction (p=0.0103) in the proportion of patients with an ASEPSIS score greater than 20, the threshold for clinically significant wound infection, indicating that even among patients who experienced wound events in the D-PLEX₁₀₀ arm, severity was meaningfully reduced. The results imply better clinical outcomes and the potential for lower hospital resource utilization. At the European Society of Clinical Microbiology and Infectious Diseases Global 2026 Congress in April 2026, new pharmacokinetic data provided further evidence for the sustained, controlled release of doxycycline by D-PLEX₁₀₀ for approximately 30 days, with minimal systemic exposure. Upcoming Expected Milestones: Completion of the NDA submission to the FDA for D-PLEX₁₀₀ imminently. Meetings with the EMA Rapporteur and Co-Rapporteur to discuss the planned MAA submission for D-PLEX₁₀₀ in the second quarter of 2026. Submission of the MAA to the EMA for D-PLEX₁₀₀ under the Centralized Procedure on the basis of therapeutic innovation in the third quarter of 2026. PDUFA target action date will be confirmed following NDA acceptance and planned for first quarter of 2027. "The first quarter of 2026 marked an important transition for PolyPid, as we moved from late-stage development to the final stage prior to drug approval, the regulatory review stage, with the initiation of our NDA submission for D-PLEX₁₀₀," said Dikla Czaczkes Akselbrad, Chief Executive Officer of PolyPid. "With submission completion expected shortly and our U.S. commercial partnership discussions now in late stages, we are looking forward to implementing our launch plans. At the same time, additional Phase 3 data continues to reinforce D-PLEX₁₀₀'s clinical and economic value proposition. We look forward to providing further updates as these milestones unfold." Financial Results for the Three Months Ended March 31, 2026 Research and development expenses for the three months ended March 31, 2026, were $5.8 million, compared to $6.1 million in the same three-month period of 2025. The decrease primarily reflects the completion of the SHIELD II Phase 3 trial and the Company's ongoing transition toward regulatory submission and commercial readiness activities. General and administrative expenses for the three months ended March 31, 2026, were $1.6 million, compared to $1.2 million for the same period of 2025. Marketing and business development expenses for the three months ended March 31, 2026, were $0.4 million, compared to $0.3 million for the same period of 2025. For the three months ended March 31, 2026, the Company had a net loss of $7.7 million, or ($0.35) per share, compared to a net loss of $8.3 million, or ($0.70) per share, in the three-month period ended March 31, 2025. Balance Sheet Highlights As of March 31, 2026, the Company had cash, cash equivalents, and short-term deposits of $10.9 million, compared to $12.9 million on December 31, 2025. The modest decrease, approximately $2 million, reflects continued operating activities, partially offset by proceeds from warrant exercises during the quarter. In early May 2026, the Company completed the repayment of its remaining $0.8 million venture loan facility, originally entered into in April 2022. As a result, the Company has fully repaid its outstanding debt obligations and has no remaining loan-related liabilities as of the date of this press release. During the first quarter of 2026, long-time shareholders continued to exercise warrants, generating approximately $4.0 million in aggregate proceeds. Together with the preserved capital from the FDA's PDUFA fee waiver, these developments further strengthen the Company's financial position as it approaches key upcoming milestones. The Company believes its current cash resources will be sufficient to fund operations into the second half of 2026 and through several significant upcoming potential milestones. Conference Call Dial-In & Webcast Information: About PolyPid PolyPid Ltd. (Nasdaq: PYPD) is an innovative biopharmaceutical company dedicated to elevating treatment effectiveness, right where care begins. The Company develops long-acting, controlled-release drugs designed to deliver therapy precisely at the site of care, addressing critical unmet medical needs across a wide and diverse pipeline spanning surgical care, metabolic diseases, and beyond. PolyPid’s lead product, D-PLEX₁₀₀, successfully met its primary and all key secondary endpoints in the landmark Phase 3 SHIELD II trial for the prevention of surgical site infections. Guided by a commitment to precision and innovation, PolyPid is redefining how therapies perform and raise the standard of patient care. For additional Company information, please visit http://www.polypid.com and follow us on Twitter (X) and LinkedIn. Forward-looking Statements This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act and other securities laws. Words such as “expects,” “anticipates,” “intends,” “plans,” “believes,” “seeks,” “estimates” and similar expressions or variations of such words are intended to identify forward-looking statements. For example, the Company is using forward-looking statements when it discusses the expected completion of the NDA submission, the Company’s expectation to hold a Scientific Advice meeting with the EMA to discuss the planned Marketing Authorization Application submission for D-PLEX₁₀₀, and the expected timing thereof, the Company’s expectations regarding a U.S. strategic partnership and launch plans, the Company’s upcoming expected milestones, D-PLEX₁₀₀'s clinical and economic value proposition and the Company’s expectation that its current cash resources will be sufficient to fund operations into the second half of 2026 and through several significant upcoming potential milestones. Forward-looking statements are not historical facts, and are based upon management’s current expectations, beliefs and projections, many of which, by their nature, are inherently uncertain. Such expectations, beliefs and projections are expressed in good faith. However, there can be no assurance that management’s expectations, beliefs and projections will be achieved, and actual results may differ materially from what is expressed in or indicated by the forward-looking statements. Forward-looking statements are subject to risks and uncertainties that could cause actual performance or results to differ materially from those expressed in the forward-looking statements. For a more detailed description of the risks and uncertainties affecting the Company, reference is made to the Company’s reports filed from time to time with the Securities and Exchange Commission, including, but not limited to, the risks detailed in the Company’s Annual Report on Form 20-F filed on February 25, 2026. Forward-looking statements speak only as of the date the statements are made. The Company assumes no obligation to update forward-looking statements to reflect actual results, subsequent events or circumstances, changes in assumptions or changes in other factors affecting forward-looking information except to the extent required by applicable securities laws. If the Company does update one or more forward-looking statements, no inference should be drawn that the Company will make additional updates with respect thereto or with respect to other forward-looking statements. References and links to websites have been provided as a convenience, and the information contained on such websites is not incorporated by reference into this press release. PolyPid is not responsible for the contents of third-party websites. Company Contact: PolyPid Ltd. Ori Warshavsky 908-858-5995 [email protected] Investor Relations Contact: Arx Investor Relations North American Equities Desk [email protected] ___________________________________ 1 ASEPSIS is an acronym of wound assessment and treatment parameters, which provides a numerical score during an inspection of the surgical site. The final score is interpreted by the severity of wound appearance and the clinical consequences of the infection. Parameters include: serous exudate, erythema, purulent exudate, separation of deep tissue and also antibiotic therapy, drainage of pus under local/general anesthesia, isolation of pathogenic bacteria and hospital stay as inpatient.