PolyPid Provides Corporate Update and Reports Third Quarter 2026 Financial Results
Azurity payments total $30 million, with over $290 million in additional milestones potentially available.
Sentiment and the balance of points
Rhea-AI Sentiment reads the wording of the document, how positive or negative its language is on a 1 to 5 scale. The balance of points shown with the takes weighs what the document actually discloses, so the two can disagree, for example when a trial that missed its main goal is described in upbeat language.
Rhea-AI Summary
PolyPid (PYPD) reported third-quarter results as D-PLEX₁₀₀ remains under FDA Priority Review, with a November 28, 2026 decision goal date. The application covers prevention of surgical site infections in colorectal surgery; a potential U.S. launch with Azurity is planned for early 2027, subject to approval.
Quarterly net loss narrowed to $5.754 million from $7.451 million a year earlier. Cash and short-term deposits totaled $15.5 million at September 30; a subsequent Azurity payment brought total receipts under the agreement to $30 million. PolyPid expects funding into 2028, including expected and potential proceeds.
The EMA validated the European application, with a decision expected in the second half of 2027. European commercial rights reverted to PolyPid after its ADVANZ agreement ended. Its expansion plans include PD01B for diabetic foot infections, with a first human study expected in the second half of 2027.
How this balance works
Rhea-AI gives every point it takes from this document a weight. Minor counts 1, Moderate 3 and Major 9, so one Major point outweighs several Minor ones. The bar adds up the weights on each side, and when neither side holds more than 65% of the total the balance reads Mixed.
It reads the document as published, with the same rules for every company, and it does not look at what the market expected or at how the stock traded, so a point can be objectively good on a day the stock falls.
Rhea-AI Sentiment measures something else, the tone of the wording.
Hollow bars mark forward-looking points. How the balance works
Positive
- Major pointAzurity payments received total $30 million, including $15 million received after September 30, 2026. 23% of market cap
- Moderate point. Forward-looking: it has not happened yet and may not happen.Over $290 million in additional milestones remain available for regulatory, launch and sales achievements. 2.3× market cap
- Moderate pointCash and short-term deposits rose to $15.5 million at September 30, 2026, from $12.9 million at December 31, 2025.
- Moderate pointFDA Priority Review is underway for D-PLEX₁₀₀, with labeling discussions ongoing and scheduled interactions on track.
- Moderate point. Forward-looking: it has not happened yet and may not happen.Potential U.S. launch is planned with Azurity for early 2027, subject to approval.
- Moderate point. Forward-looking: it has not happened yet and may not happen.EMA validation initiated formal review of D-PLEX₁₀₀; a decision is expected in the second half of 2027.
- Moderate pointExclusive European commercialization rights reverted to PolyPid; discussions with potential commercial partners are active.
14 minor points
- Minor pointThird-quarter net loss narrowed to $5.754 million, or $0.24 per share, from $7.451 million, or $0.37, a year earlier.
- Minor pointNine-month net loss narrowed to $21.331 million, or $0.94 per share, from $25.696 million, or $1.72.
- Minor point. Forward-looking: it has not happened yet and may not happen.Commercial supply payments and royalties include a pre-negotiated unit transfer price and mid-teen to mid-twenties royalties on U.S. and Canadian sales.
- Minor point. Forward-looking: it has not happened yet and may not happen.NTAP application submitted seeks additional inpatient hospital reimbursement; a CMS decision is expected in August 2027.
- Minor point. Forward-looking: it has not happened yet and may not happen.Broader abdominal-surgery label expansion is planned, with FDA communications expected to begin in the fourth quarter of 2026.
- Minor point. Forward-looking: it has not happened yet and may not happen.Canadian New Drug Submission for D-PLEX₁₀₀ is expected in 2027.
- Minor point. Forward-looking: it has not happened yet and may not happen.PD01B pipeline expansion targets diabetic foot infections; PolyPid holds worldwide commercial rights.
- Minor point. Forward-looking: it has not happened yet and may not happen.PD01B FDA meeting and first human study are both expected in the second half of 2027.
- Minor pointPD03A obesity program continues in early preclinical development.
- Minor pointGeneral and administrative expenses fell to $1.529 million in the quarter from $1.766 million a year earlier.
- Minor pointNine-month general and administrative expenses fell to $4.384 million from $5.427 million.
- Minor pointMarketing and business development expenses fell to $418,000 quarterly and $1.291 million year-to-date, from $432,000 and $1.421 million.
- Minor pointOther income of $2.548 million reflects recognition of previously deferred revenue after the ADVANZ agreement ended.
- Minor pointCurrent maturities of long-term debt fell to zero at September 30, 2026, from $988,000 at December 31, 2025.
Negative
- Moderate pointD-PLEX₁₀₀ approval remains pending; the November 28, 2026 FDA goal date is not an approval.
- Moderate point. Forward-looking: it has not happened yet and may not happen.Funding into 2028 depends on expected Azurity proceeds and future potential proceeds alongside current cash.
- Moderate pointOutstanding ordinary shares increased to 21,125,704 at September 30, 2026, from 18,204,002 at December 31, 2025.
- Moderate pointShareholders' equity declined to $3.901 million at September 30, 2026, from $10.973 million at December 31, 2025.
- Minor pointThird-quarter research and development expenses rose to $6.523 million from $5.257 million a year earlier.
- Minor pointNine-month research and development expenses rose to $18.404 million from $17.589 million.
News Explained
PolyPid reported 21,125,704 ordinary shares issued and outstanding at September 30, 2026, versus 18,204,002 at December 31, 2025; for holders whose share count did not change, the larger share base means a smaller proportional ownership.
Key Figures
- FDA PDUFA goal date
- November 28, 2026
- D-PLEX₁₀₀ NDA under Priority Review
- Azurity payments received
- $30 million
- $15 million upfront and $15 million after FDA acceptance of the NDA
- Additional milestone eligibility
- Over $290 million
- Regulatory, launch and sales-based milestones
- Third-quarter net loss
- $5.8 million vs. $7.5 million
- Three months ended September 30, 2026 vs. the same period in 2025
- Nine-month net loss
- $21.3 million vs. $25.7 million
- Nine months ended September 30, 2026 vs. the same period in 2025
- Cash, cash equivalents and short-term deposits
- $15.5 million
- As of September 30, 2026
- EMA decision expected
- Second half of 2027
- D-PLEX₁₀₀ MAA
- CMS NTAP decision expected
- August 2027
- D-PLEX₁₀₀ NTAP application
Previous Earnings Reports
-
Established Azurity's $30 million upfront and near-term payment structure, now reported as received.
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
Key Terms
nda regulatory
pdufa regulatory
maa regulatory
ntap regulatory
AI-generated analysis. How Rhea-AI works. Not financial advice.
D-PLEX₁₀₀ NDA Under FDA Priority Review with PDUFA Goal Date of November 28, 2026; U.S. Commercial Launch Preparations Ongoing
Expanding D-PLEX₁₀₀ Globally: MAA Submitted and Validated by the EMA and European Commercialization Rights to D-PLEX₁₀₀ Regained
“PolyPid 2030” Growth Strategy Unveiled, Introducing PD01B, a New Kynatrix™-Based Product Candidate for the Treatment of Diabetic Foot Infections
Conference Call Scheduled for Today at 8:30 AM ET
PETACH TIKVA, Israel, Nov. 11, 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 nine months ended September 30, 2026.
Recent Corporate Highlights:
D-PLEX₁₀₀ Under U.S. Food and Drug Administration (“FDA”) Priority Review; PolyPid and Azurity Preparing for Potential U.S. Launch:
- The FDA is reviewing the New Drug Application (“NDA”) for D-PLEX₁₀₀ for the prevention of surgical site infections (“SSIs”) in patients undergoing colorectal surgery under Priority Review, with a Prescription Drug User Fee Act (“PDUFA”) goal date of November 28, 2026. Labeling discussions with the FDA are underway, and all scheduled FDA interactions are on track and aligned with the PDUFA goal date.
- Subject to approval, PolyPid and Azurity Pharmaceuticals (“Azurity”) are preparing for the U.S. commercial launch of D-PLEX₁₀₀ in early 2027. Azurity is building its U.S. commercial organization, with an existing hospital footprint that reaches more than 1,700 leading U.S. hospitals and academic centers.
- A New Technology Add-on Payment (“NTAP”) application for D-PLEX₁₀₀ has been submitted to the Centers for Medicare & Medicaid Services (“CMS”), with a decision expected in August 2027. If granted, NTAP would provide additional hospital reimbursement for D-PLEX₁₀₀ in the inpatient setting.
- PolyPid has received a total of
$30 million in upfront and near-term milestone payments from Azurity, comprising$15 million upon signing of the agreement in July 2026 and an additional$15 million milestone payment following FDA acceptance of the NDA, received subsequent to September 30, 2026. PolyPid remains eligible for over$290 million in additional regulatory, launch and sales-based milestone payments. In addition, upon commercialization, PolyPid will receive a pre-negotiated transfer price for each unit of D-PLEX₁₀₀ it manufactures and supplies to Azurity, as well as tiered royalties ranging from mid-teen to mid-twenties percentages on sales in the U.S. and Canada.
Expanding D-PLEX₁₀₀ Globally:
- On September 14, 2026, PolyPid submitted its Marketing Authorization Application (“MAA”) for D-PLEX₁₀₀ to the European Medicines Agency (“EMA”) under the Centralized Procedure, meeting its previously communicated third quarter 2026 timeline. Subsequent to quarter end, the EMA validated the MAA, initiating its formal review. A decision is expected in the second half of 2027.
- PolyPid and ADVANZ PHARMA mutually agreed to terminate their 2022 exclusive License, Distribution and Supply Agreement for D-PLEX₁₀₀ in Europe, and exclusive European commercialization rights to D-PLEX₁₀₀ have reverted to PolyPid.
- The Company is in active discussions with potential commercial partners in Europe.
“PolyPid 2030” Strategy and Expanded Kynatrix™ Pipeline:
- Subsequent to quarter end, on October 28, 2026, PolyPid hosted its “PolyPid 2030” virtual investor day and KOL event, outlining a long-term growth strategy built on three levers: maximizing D-PLEX₁₀₀ through the Azurity partnership, including label expansion beyond colorectal surgery; expanding D-PLEX₁₀₀ into Europe and other territories through partnerships; and building a Kynatrix-based pipeline.
- Introduced PD01B, a new hyper-localized Kynatrix-based product candidate for the treatment of moderate to severe diabetic foot infections following wound debridement. PD01B is designed to deliver high-concentration doxycycline in the wound for weeks and is expected to be developed under its own NDA, separate from D-PLEX₁₀₀. PD01B leverages the active ingredient, Kynatrix technology, manufacturing site and processes, and preclinical and safety foundation established for D-PLEX₁₀₀. PolyPid holds worldwide commercial rights to PD01B.
- PolyPid’s long-acting obesity program, PD03A, continues in early preclinical development.
“With our PDUFA goal date fast approaching, this is a defining moment for PolyPid,” said Dikla Czaczkes Akselbrad, Chief Executive Officer of PolyPid. “We have a committed partner in Azurity preparing to bring D-PLEX₁₀₀ to surgeons and patients in the U.S., subject to approval, and we now hold full rights to D-PLEX₁₀₀ in Europe. As D-PLEX₁₀₀ moves toward commercialization, we are leveraging the Kynatrix technology to strengthen our pipeline. At our recent investor day, we presented how it can reach beyond surgical site infections, starting with PD01B in diabetic foot infections, a serious condition where systemic antibiotics often fall short. We are now focused on executing our PolyPid 2030 plan, and we look forward to sharing our progress.”
Upcoming Expected Milestones:
- PDUFA goal date for the D-PLEX₁₀₀ NDA of November 28, 2026.
- Initiation of FDA communications on label expansion of D-PLEX₁₀₀ into broader abdominal surgery in the fourth quarter of 2026.
- Potential U.S. commercial launch of D-PLEX₁₀₀ by Azurity in early 2027.
- New Drug Submission for D-PLEX₁₀₀ in Canada in 2027.
- CMS decision on NTAP for D-PLEX₁₀₀ in August 2027.
- EMA decision on the D-PLEX₁₀₀ MAA in the second half of 2027.
- PD01B pre-Investigational New Drug (“IND”) meeting with the FDA and first-in-human study, both expected in the second half of 2027.
Financial Results for the Three Months Ended September 30, 2026
- Research and development expenses for the three months ended September 30, 2026, were
$6.5 million , compared to$5.3 million in the same three-month period of 2025. The increase was primarily due to the ongoing NDA-related activities and continued commercial readiness preparation. - General and administrative expenses for the three months ended September 30, 2026, were
$1.5 million , compared to$1.8 million for the same period of 2025. The decrease was primarily due to the decrease of non-cash expenses related to performance-based options following the positive Phase 3 SHIELD II topline results, which triggered the vesting of those options. - Marketing and business development expenses for the three months ended September 30, 2026, were
$0.4 million , compared to$0.4 million for the same period of 2025. - Other income for the three months ended September 30, 2026, was
$2.5 million , reflecting the recognition of previously deferred revenue following the termination of the ADVANZ agreement on September 30, 2026. - For the three months ended September 30, 2026, the Company had a net loss of
$5.8 million , or$(0.24) per share, compared to a net loss of$7.5 million , or$(0.37) per share, in the three-month period ended September 30, 2025.
Financial Results for the Nine Months Ended September 30, 2026
- Research and development expenses for the nine months ended September 30, 2026, were
$18.4 million , compared to$17.6 million in the same nine-month period of 2025. The increase was primarily due to the ongoing NDA-related activities and continued commercial readiness preparation. - General and administrative expenses for the nine months ended September 30, 2026, were
$4.4 million , compared to$5.4 million for the same period of 2025. The decrease was primarily due to the decrease of non-cash performance-based options vesting expenses. - Marketing and business development expenses for the nine months ended September 30, 2026, were
$1.3 million , compared to$1.4 million for the same period of 2025. - Other income for the nine months ended September 30, 2026, was
$2.5 million , as described above. - For the nine months ended September 30, 2026, the Company had a net loss of
$21.3 million , or$(0.94) per share, compared to a net loss of$25.7 million , or$(1.72) per share, in the nine-month period ended September 30, 2025.
Balance Sheet Highlights
- As of September 30, 2026, the Company had cash, cash equivalents and short-term deposits of
$15.5 million , compared to$12.9 million on December 31, 2025. Following the end of the quarter, the Company received an additional$15 million milestone payment from its U.S. partner, Azurity, following the FDA’s acceptance of the D-PLEX₁₀₀ NDA, further strengthening its balance sheet. - The Company believes that its current cash position, together with its expected proceeds from its commercialization agreement with Azurity, 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:
| Date: | Wednesday, November 11, 2026 |
| Time: | 8:30 AM Eastern Time |
| Conference Call: | https://register-conf.media-server.com/register/BIa693ec3496b1413b8682b952b2ff9e10 |
| Webcast: | https://edge.media-server.com/mmc/p/rsj3o3mw |
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 FDA’s review of the D-PLEX₁₀₀ NDA, including the PDUFA goal date, the outcome and timing of such review, the Company’s ongoing labeling discussions with the FDA, and the potential approval of D-PLEX₁₀₀; the anticipated timing of a potential U.S. commercial launch of D-PLEX₁₀₀ by Azurity and Azurity’s launch preparations; potential reimbursement for D-PLEX₁₀₀, including the anticipated timing of a CMS decision on NTAP; the timing, receipt and amount of regulatory, launch and sales-based milestone payments, transfer price payments and royalties under the Company’s agreement with Azurity; the potential label expansion of D-PLEX₁₀₀, including the planned initiation of communications with the FDA and the anticipated timing of potential label expansion; the EMA’s review of the MAA for D-PLEX₁₀₀, the anticipated timing of a decision and a potential EU launch; the Company’s plans for the commercialization of D-PLEX₁₀₀ in Europe and other territories, including potential partnerships; the planned New Drug Submission for D-PLEX₁₀₀ in Canada; the Company’s “PolyPid 2030” growth strategy; the design, development plan, regulatory pathway and anticipated timing of a pre-IND meeting and first-in-human study for PD01B, and its potential benefits; the Company’s plans to advance Kynatrix technology through additional pipeline programs, including its long-acting obesity program, PD03A, and the anticipated development and potential applications of such programs; the Company’s belief that its current cash position, together with its expected proceeds from its commercialization agreement with Azurity, as well as future potential proceeds, will be sufficient to fund operations into 2028 and through several significant upcoming potential milestones; and the therapeutic and commercial potential of D-PLEX₁₀₀. 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
IR@Polypid.com
Investor Relations Contact:
Arx Investor Relations
North American Equities Desk
polypid@arxhq.com
| INTERIM CONDENSED CONSOLIDATED BALANCE SHEETS (UNAUDITED) | |||||||
| U.S. dollars in thousands | |||||||
| September 30, | December 31, | ||||||
| 2026 | 2025 | ||||||
| ASSETS | |||||||
| CURRENT ASSETS: | |||||||
| Cash and cash equivalents | $ | 5,414 | $ | 6,402 | |||
| Restricted deposits | 201 | 193 | |||||
| Short-term deposits | 10,085 | 6,531 | |||||
| Accounts receivable | 15,000 | - | |||||
| Pre-launch inventories | 1,567 | 1,106 | |||||
| Prepaid expenses and other current assets | 901 | 995 | |||||
| Total current assets | 33,168 | 15,227 | |||||
| NON-CURRENT ASSETS: | |||||||
| Property and equipment, net | 4,553 | 5,094 | |||||
| Operating lease right-of-use assets | 1,181 | 1,675 | |||||
| Long-term deposits | 318 | 311 | |||||
| Other long-term asset | 900 | - | |||||
| Total non-current assets | 6,952 | 7,080 | |||||
| Total assets | $ | 40,120 | $ | 22,307 | |||
| INTERIM CONDENSED CONSOLIDATED BALANCE SHEETS (UNAUDITED) | |||||||
| U.S. dollars in thousands (except share and per share data) | |||||||
| September 30, | December 31, | ||||||
| 2026 | 2025 | ||||||
| LIABILITIES AND SHAREHOLDERS' EQUITY | |||||||
| CURRENT LIABILITIES: | |||||||
| Trade payables | $ | 1,573 | $ | 2,856 | |||
| Accrued expenses and other current liabilities | 2,981 | 2,734 | |||||
| Current maturities of long-term debt | - | 988 | |||||
| Current maturities of operating lease liabilities | 1,030 | 1,161 | |||||
| Total current liabilities | 5,584 | 7,739 | |||||
| NON-CURRENT LIABILITIES: | |||||||
| Deferred revenues | 30,000 | 2,548 | |||||
| Long-term operating lease liabilities | 227 | 647 | |||||
| Long-term other liabilities | 408 | 400 | |||||
| Total non-current liabilities | 30,635 | 3,595 | |||||
| COMMITMENTS AND CONTINGENT LIABILITIES | |||||||
| SHAREHOLDERS' EQUITY: | |||||||
| Ordinary shares, no par value - Authorized: 107,800,000 shares at September 30, 2026 and December 31, 2025; Issued and outstanding: 21,125,704 and 18,204,002 shares at September 30, 2026 and December 31, 2025, respectively | - | - | |||||
| Additional paid-in capital | 326,732 | 312,473 | |||||
| Accumulated deficit | (322,831 | ) | (301,500 | ) | |||
| Total shareholders' equity | 3,901 | 10,973 | |||||
| Total liabilities and shareholders' equity | $ | 40,120 | $ | 22,307 | |||
| INTERIM CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (UNAUDITED) | |||||||||||||||
| U.S. dollars in thousands (except share and per share data) | |||||||||||||||
| Nine Months Ended | Three Months Ended | ||||||||||||||
| September 30, | September 30, | ||||||||||||||
| 2026 | 2025 | 2026 | 2025 | ||||||||||||
| Operating expenses: | |||||||||||||||
| Research and development | $ | 18,404 | $ | 17,589 | $ | 6,523 | $ | 5,257 | |||||||
| Marketing and business development | 1,291 | 1,421 | 418 | 432 | |||||||||||
| General and administrative | 4,384 | 5,427 | 1,529 | 1,766 | |||||||||||
| Other income | (2,548 | ) | - | (2,548 | ) | - | |||||||||
| Operating loss | 21,531 | 24,437 | 5,922 | 7,455 | |||||||||||
| Loss on extinguishment of debt | - | 512 | - | - | |||||||||||
| Financial expense (income), net | (208 | ) | 661 | (170 | ) | (26 | ) | ||||||||
| Loss before income tax | 21,323 | 25,610 | 5,752 | 7,429 | |||||||||||
| Income tax expenses | 8 | 86 | 2 | 22 | |||||||||||
| Net loss | $ | 21,331 | $ | 25,696 | $ | 5,754 | $ | 7,451 | |||||||
| Basic and diluted loss per ordinary share | $ | 0.94 | $ | 1.72 | $ | 0.24 | $ | 0.37 | |||||||
| Weighted average number of ordinary shares used in computing basic and diluted loss per share | 22,751,434 | 14,920,521 | 23,677,711 | 20,054,071 | |||||||||||
FAQ
AI-generated questions and answers. How Rhea-AI works. Not financial advice.
When is PolyPid's D-PLEX₁₀₀ FDA decision expected?
D-PLEX₁₀₀ has an FDA decision goal date of November 28, 2026 under Priority Review. The application seeks approval to prevent surgical site infections in patients undergoing colorectal surgery. PolyPid and Azurity are preparing for a potential U.S. launch in early 2027, subject to approval.
What were PolyPid's third-quarter 2026 financial results?
PolyPid reported a $5.754 million net loss, or $0.24 per share, compared with $7.451 million, or $0.37 per share, a year earlier. Research and development expenses increased to $6.523 million from $5.257 million, while general and administrative expenses decreased to $1.529 million from $1.766 million.
How does PolyPid plan to develop PD01B for diabetic foot infections?
PolyPid expects PD01B to be developed under its own New Drug Application, separate from D-PLEX₁₀₀. The candidate targets moderate to severe diabetic foot infections following wound debridement. It uses the active ingredient, Kynatrix technology, manufacturing site and processes, and preclinical and safety foundation established for D-PLEX₁₀₀.