PolyPid（PYPD）2026年第2四半期決算説明会：D-PLEX100の優先審査とAzurityとの契約

主要なポイント

• 米国食品医薬品局（FDA）は2026年7月27日、PolyPidのD-PLEX100に関する新薬承認申請（NDA）を受理し、申請審査上の問題を指摘することなく優先審査を指定しました。PDUFA（ユーザー新薬承認法）目標期日は2026年11月28日です。
• PolyPidはAzurity Pharmaceuticalsと米国およびカナダにおける独占的販売権契約を締結しました。同社は契約時一時金および短期マイルストーン支払いとして3000万ドルを確保し、さらに2億9000万ドルを超える追加マイルストーンを受け取る権利を得ています。
• また、本契約に基づき、PolyPidには10%台半ばから20%台半ばの段階的ロイヤルティに加え、Azurityに供給する1ユニットごとに合意された譲渡価格が支払われます。
• 2026年第2四半期の純損失は780万ドル（1株当たり0.35ドル）となり、前年同期（2025年第2四半期）の1000万ドル（1株当たり0.78ドル）から縮小しました。
• 経営陣は、手元資金、販売権契約による収入、および将来の潜在的収入によって、2028年までの事業資金をまかなえる見込みであるとしています。また、PolyPidに当面の資金調達の必要性はないと述べました。
• PolyPidは2026年第3四半期に欧州医薬品庁（EMA）へD-PLEX100の販売承認申請（MAA）を提出する予定です。経営陣は、承認を得られればAzurityが2027年初頭に米国で製品を発売すると見込んでいます。

主要財務データ

2026年上半期（最初の6カ月間）の純損失は1560万ドルとなり、前年同期の1820万ドルから縮小しました。

2026年6月30日時点で、PolyPidの現金および現金同等物の残高は660万ドルでした。これは2025年12月31日時点の現金、現金同等物および短期預金の合計1290万ドルと比較されます。四半期末以降、同社はAzurityから契約時一時金1500万ドルを受領し、さらにFDAによるNDA受理に伴い1500万ドルを受領しました。

2025年6月に発行されたワラントのうち約730万ドル分が未行使のまま残っており、行使期限は2027年6月です。

事業および業績の動向

D-PLEX100は、腹部大腸手術を受ける患者の術後感染症予防を目的としてFDAの審査を受けています。経営陣によると、優先審査の指定により審査期間は標準的な10カ月から6カ月に短縮されました。

PolyPidは、FDAによる事前承認査察に向けてイスラエルの製造施設を準備しています。同施設は直近では2025年9月にイスラエル保健省による査察を受けるなど、4回連続でGMP査察に合格しています。経営陣はまた、パートナー企業のデューデリジェンス、外部アドバイザー、複数の模擬査察を挙げ、査察への準備が整っていることを強調しました。

Azurityとの契約に基づき、PolyPidはグローバルな製造責任と規制戦略を維持します。Azurityは、営業組織の拡大、全国主要アカウント計画、メディカル・アフェアーズ、契約交渉、薬局チャネルの準備など、米国およびカナダでの商業化活動を統括します。

Azurityは米国で200名以上の商業化担当従業員を擁し、1,700以上の病院および学術機関との提携関係を有しています。経営陣は、市場アクセスは病院ごと、および統合医療供給網（IDN）ごとに段階的に進められると述べました。

このパートナーシップには、D-PLEX100の適応拡大の可能性に向けたAzurity資金提供による共同開発枠組みが含まれています。経営陣は、検討中の優先領域として、心臓手術（特にCABG）、整形外科手術（股関節および膝関節手術を含む）、ならびに乳房切除および再建術を挙げました。

PolyPidはまた、独自技術であるKynatrixの完全な所有権を維持しています。同社は持続性代謝プログラムを含む治療への応用を模索していますが、具体的な開発スケジュールは示していません。

経営陣のガイダンス

経営陣は、PolyPidの現在の現金リソース、Azurityとの契約による収入、および将来の潜在的収入によって、2028年までの事業活動およびいくつかの潜在的マイルストーン達成までの資金が確保されると見込んでいます。

経営陣が挙げた主なマイルストーンは以下の通りです：

• PolyPidの製造施設に対するFDAの事前承認査察。
• 2026年11月28日のD-PLEX100のPDUFA目標期日。
• 中央審査方式（Centralized Procedure）に基づく2026年第3四半期のEMAへの申請予定。
• 規制当局の承認を条件とした、2027年初頭のAzurityによる米国での商業発売予定。

PolyPidは、合意された譲渡価格契約に基づきAzurityへD-PLEX100ユニットを販売した時点で製品供給による売上を計上する見込みです。ロイヤルティおよびマイルストーン収益は、関連する事象が発生した時点で計上されます。

リスクと注視点

D-PLEX100は引き続きFDAの審査および製造施設の事前承認査察の対象となります。経営陣は具体的な査察日程を明言しませんでしたが、FDAとの対話には予想される監査に関する事項が含まれていると述べました。

商業的な普及は段階的に進むと見込まれています。発売初期の指標としては、病院採用医薬品集（フォーミュラリー）への追加、薬事委員会（P&T委員会）での審査、パイロットプログラム、医師による使用状況、保険償還の進捗、および新規技術追加支払い（NTAP）制度の適用状況などが挙げられます。

計画されている欧州での申請も引き続き規制当局の審査対象となります。経営陣は、主査（Rapporteur）および副主査（Co-Rapporteur）との協議において、追加データを必要とする問題や、2026年第3四半期に予定されている申請を遅延させるような変更点は特定されなかったと述べました。

アナリスト質疑応答のハイライト

• FDAの査察：経営陣は具体的な日程の言及を控えましたが、NDA審査期間中に想定される監査に関してFDAと継続的に対話を行っていることを確認しました。
• 製造のデューデリジェンス：Azurityおよびその他の候補パートナーは、PolyPidのイスラエル施設、CMC（製造品質管理）プロセス、および商業規模の製造能力について現地調査を実施しました。
• 発売準備：Azurityは市場調査、価格設定、キーオピニオンリーダー（KOL）とのエンゲージメント、市場アクセス、契約交渉業務を引き継ぎました。経営陣によると、マーケティングおよび契約チームはすでに配置されています。
• NTAPプロセス：経営陣によると、D-PLEX100はNTAP申請前に承認を取得している必要はなく、FDAの審査下にあれば十分です。Azurityは次会計年度の10月の期限に向けて準備を進めています。
• 発売後の指標：PolyPidは、病院での採用承認、薬事（P&T）委員会での審査、パイロットプログラム、医師の使用状況、保険償還の進捗、およびAzurity契約に基づく最低取引数量をモニタリングする計画です。
• 欧州での申請：経営陣は、EMA関連の協議は建設的であり、2026年第3四半期の申請目標時期を遅らせるような重大な追加データの要求はなかったと述べました。

決算説明会トランスクリプト全文

決算説明会の完全なトランスクリプト

経営陣による説明

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.

質疑応答

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. Thank you for participating. You may now disconnect.