PolyPid Provides Corporate Update and Reports Second Quarter 2025 Financial Results
PolyPid (NASDAQ:PYPD) announced significant milestones in Q2 2025, highlighted by positive Phase 3 SHIELD II trial results for D-PLEX₁₀₀. The trial demonstrated a 58% reduction in surgical site infections (SSIs) and met its primary efficacy endpoint with a 38% reduction (p<0.005).
Key developments include plans for NDA submission in Q1 2026, unveiling of a novel long-acting GLP-1 delivery platform for obesity and diabetes, and appointment of Dr. Nurit Tweezer-Zaks as CMO. The company reported a Q2 2025 net loss of $10.0 million ($0.78 per share) and strengthened its balance sheet through warrant exercises, extending cash runway into 2026 with $29.5 million in cash and equivalents.
PolyPid (NASDAQ:PYPD) ha annunciato traguardi importanti nel secondo trimestre 2025, in particolare risultati positivi nella fase 3 dello studio SHIELD II su D-PLEX₁₀₀. Lo studio ha mostrato una riduzione del 58% delle infezioni del sito chirurgico (SSI) e ha raggiunto l'endpoint primario di efficacia con una riduzione del 38% (p<0.005).
Tra gli sviluppi chiave figurano i piani per la presentazione della NDA nel primo trimestre 2026, la presentazione di una nuova piattaforma a lunga durata per la somministrazione di GLP-1 per obesità e diabete, e la nomina della Dott.ssa Nurit Tweezer-Zaks come Direttore Medico (CMO). La società ha riportato una perdita netta nel Q2 2025 di $10.0 million ($0.78 per azione) e ha rafforzato il bilancio tramite l'esercizio di warrant, estendendo la liquidità fino al 2026 con $29.5 million in contanti e equivalenti.
PolyPid (NASDAQ:PYPD) anunció hitos importantes en el segundo trimestre de 2025, destacando los resultados positivos del ensayo de fase 3 SHIELD II para D-PLEX₁₀₀. El ensayo demostró una reducción del 58% en las infecciones del sitio quirúrgico (SSI) y cumplió su objetivo primario de eficacia con una reducción del 38% (p<0.005).
Los avances clave incluyen planes para la presentación de la NDA en el primer trimestre de 2026, la presentación de una nueva plataforma de liberación prolongada de GLP-1 para obesidad y diabetes, y el nombramiento de la Dra. Nurit Tweezer-Zaks como CMO. La compañía reportó una pérdida neta en el 2T 2025 de $10.0 million ($0.78 por acción) y fortaleció su balance mediante el ejercicio de warrants, extendiendo su liquidez hasta 2026 con $29.5 million en efectivo y equivalentes.
PolyPid (NASDAQ:PYPD)� 2025� 2분기� 중요� 이정표를 발표했으�, 그중 D-PLEX₁₀₀� 대� 3� SHIELD II 시험� 긍정� 결과가 눈에 띕니�. 해당 시험은 수술 부� 감염(SSI)� 58% 감소시켰� 1� 유효� 평가에서 38% 감소� 목표� 달성했습니다 (p<0.005).
주요 성과로는 2026� 1분기 NDA 제출 계획, 비만 � 당뇨병용 장기 지속형 GLP-1 전달 플랫� 공개, Nurit Tweezer-Zaks 박사� CMO 임명 등이 포함됩니�. 회사� 2025� 2분기 순손� $10.0 million (주당 $0.78)� 보고했으�, 워런� 행사� 재무구조� 강화� 현금 유동성을 2026년까지 연장, $29.5 million� 현금 � 현금성자산을 확보했습니다.
PolyPid (NASDAQ:PYPD) a annoncé des étapes importantes au deuxième trimestre 2025, notamment des résultats positifs de l'essai de phase 3 SHIELD II sur D-PLEX₁₀₀. L'essai a montré une réduction de 58 % des infections du site opératoire (SSI) et a atteint son critère d'efficacité primaire avec une réduction de 38 % (p<0.005).
Parmi les développements clés figurent les plans de dépôt de la NDA au premier trimestre 2026, la présentation d'une nouvelle plateforme de délivrance prolongée de GLP�1 pour l'obésité et le diabète, et la nomination de la Dre Nurit Tweezer‑Zaks au poste de CMO. La société a enregistré une perte nette au T2 2025 de $10.0 million (0,78 $ par action) et a renforcé son bilan grâce à l'exercice de warrants, prolongeant sa trésorerie jusqu'en 2026 avec $29.5 million en liquidités et équivalents.
PolyPid (NASDAQ:PYPD) meldete im zweiten Quartal 2025 bedeutende Meilensteine, allen voran positive Ergebnisse der Phase�3‑Studie SHIELD II zu D-PLEX₁₀₀. Die Studie zeigte eine Reduktion der postoperativen Wundinfektionen (SSIs) um 58% und erreichte den primären Wirksamkeitsendpunkt mit einer 38%igen Reduktion (p<0.005).
Wesentliche Entwicklungen umfassen Pläne zur NDA‑Einreichung im 1. Quartal 2026, die Vorstellung einer neuen langwirksamen GLP�1‑Verabreichungsplattform für Adipositas und Diabetes sowie die Ernennung von Dr. Nurit Tweezer‑Zaks zur Chief Medical Officer (CMO). Das Unternehmen meldete einen Nettoverlust im 2. Quartal 2025 von $10.0 million ($0.78 je Aktie) und stärkte seine Bilanz durch die Ausübung von Warrants, wodurch die finanzielle Reichweite bis 2026 verlängert wurde und $29.5 million in bar und gleichwertigen Mitteln vorhanden sind.
- Phase 3 SHIELD II trial showed significant 58% reduction in SSIs
- Cash position strengthened to $29.5 million, extending runway into 2026
- Development of novel 60-day GLP-1 delivery platform for obesity/diabetes market
- Fast Track and Breakthrough Therapy designations may accelerate regulatory review
- Strong safety profile demonstrated in Phase 3 trial
- Increased net loss to $10.0 million in Q2 2025 vs $6.3 million in Q2 2024
- R&D expenses increased 29% to $6.2 million in Q2 2025
- G&A expenses more than doubled to $2.5 million in Q2 2025
Insights
PolyPid's positive Phase 3 D-PLEX₁₀₀ data shows 58% SSI reduction, setting stage for 2026 NDA filing with strengthened financials.
PolyPid has achieved a significant clinical milestone with its D-PLEX₁₀₀ product, reporting positive top-line results from the Phase 3 SHIELD II trial for preventing surgical site infections (SSIs) in colorectal surgeries. The data showed a statistically significant 38% reduction (p<0.005) in the primary endpoint and an impressive 58% reduction in overall SSI rates compared to standard care.
The safety profile appears favorable with no difference in serious treatment-emergent adverse events between treatment arms. This clean safety data alongside robust efficacy strengthens D-PLEX₁₀₀'s regulatory case and commercial potential in the infection prevention market.
The company is leveraging Fast Track and Breakthrough Therapy designations for an expedited regulatory pathway, with NDA submission planned for Q1 2026. These designations signal the FDA's recognition of D-PLEX₁₀₀'s potential to address significant unmet needs in surgical infection prevention.
Beyond D-PLEX₁₀₀, the company has unveiled a novel GLP-1 delivery platform targeting the booming obesity and diabetes markets. This system aims to provide approximately 60-day sustained release without initial drug bursting—a technical achievement that could significantly improve patient compliance in the rapidly expanding GLP-1 market.
From a financial perspective, the company has strengthened its balance sheet through warrant exercises, extending its cash runway into 2026. With
Operating expenses increased year-over-year, with R&D expenses rising to
PolyPid's Phase 3 success positions it for strategic partnerships, with expanded pipeline and sufficient funding through expected FDA review.
PolyPid's successful Phase 3 SHIELD II trial represents a crucial inflection point that transforms the company's commercial outlook. The strong efficacy data showing a 58% reduction in SSIs dramatically enhances D-PLEX₁₀₀'s commercial value proposition, especially considering the significant cost burden of surgical site infections to healthcare systems.
The company's disclosure of ongoing partnership discussions with multiple potential U.S. partners is particularly noteworthy. Rather than pursuing commercialization independently, this strategy could optimize D-PLEX₁₀₀'s market potential while reducing capital requirements and execution risk. For a smaller biopharma company like PolyPid, securing a commercial partner with established hospital market access would significantly de-risk the commercialization phase.
The expansion into the GLP-1 delivery space represents an astute strategic pivot. By leveraging their drug delivery expertise to enter the rapidly growing obesity and diabetes markets, PolyPid is diversifying beyond surgical applications. A 60-day sustained-release GLP-1 formulation would address a clear unmet need for less frequent dosing in a market projected to reach
From a financial standpoint, the warrant exercise has meaningfully strengthened the balance sheet, extending runway well into 2026. This timeline strategically covers the anticipated NDA review period and positions the company to either negotiate partnerships from a position of strength or prepare for potential commercial launch.
The increased expenses (
Positive Phase 3 SHIELD II Trial Results - D-PLEX₁₀₀ successfully met its primary efficacy endpoint and demonstrated
NDA submission expected in Q1 2026
Unveiled a Long-Acting GLP-1 Receptor Agonists Delivery Platform Targeting the Obesity and Diabetes Market
Successful Warrant Exercise Significantly Strengthened Balance Sheet with Cash Runway into 2026
Conference Call Scheduled for Today at 8:30 AM ET
PETACH TIKVA, Israel, Aug. 13, 2025 (GLOBE NEWSWIRE) -- PolyPid Ltd. (Nasdaq: PYPD) ("PolyPid" or the "Company"), a late-stage biopharma company aiming to improve surgical outcomes, today provided a corporate update and reported financial results for the three and six months ended June 30, 2025.
Recent Corporate Highlights:
- Positive Phase 3 Data and Additional Clinical Insights: Reported positive top-line results from the SHIELD II Phase 3 trial of D-PLEX₁₀₀ for the prevention of abdominal colorectal surgical site infections (SSIs). The study showed statistically significant reduction of
38% (p<0.005) of the primary endpoint in addition to demonstrating a robust58% reduction in the rate of SSIs in patients treated with D-PLEX₁₀₀ arm versus standard of care arm (p<0.005), including a significant reduction in deep SSIs. - Recently Evaluated Safety Data: Further analysis of the Phase 3 SHIELD II trial revealed a good safety profile with no difference in serious treatment-emergent adverse events between patients treated with D-PLEX₁₀₀ arm versus standard of care arm.
- Regulatory Pathway Advancement: Following the positive Phase 3 data, the Company is on track with its New Drug Application (NDA) preparation. The Company anticipates submitting the NDA to the U.S. Food and Drug Administration in early 2026, leveraging its Fast Track and Breakthrough Therapy designations to shorten regulatory review.
- Partnership Discussions: The Company continues to advance its commercialization preparations while simultaneously advancing strategic partnership discussions and due diligence with multiple potential partners in the United States to maximize D-PLEX₁₀₀'s market potential.
- Strengthened Pipeline with Novel GLP-1 Delivery Platform: Recently made significant progress on the Company's GLP-1 program. This initiative leverages the Company's extensive and long-term experience and aims to deliver approximately 60 days no-burst GLP-1 for improved patient compliance and enhanced therapeutic outcomes in the rapidly growing obesity and diabetes market.
- Appointed New Chief Medical Officer: On August 12, 2025, the Company announced the appointment of Dr. Nurit Tweezer-Zaks, M.D., M.B.A., as Chief Medical Officer of the Company, transitioning from her role on PolyPid's Board of Directors. Dr. Tweezer-Zaks brings extensive medical, research and development (R&D), and business development expertise to this executive position, strengthening the Company's leadership team as it advances toward NDA submission and commercial preparations following the positive Phase 3 SHIELD II results.
- Financial Position Strengthened: Completed a warrant exercise inducement transaction significantly strengthened the Company's balance sheet, extending its cash runway well into 2026.
"The second quarter of 2025 was transformational for PolyPid with the successful completion of our SHIELD II Phase 3 trial, which demonstrated significant clinical benefits of D-PLEX₁₀₀ in preventing SSIs in abdominal colorectal surgeries," stated Dikla Czaczkes Akselbrad, PolyPid's Chief Executive Officer. "The positive data has generated substantial interest from potential commercial partners and reinforced our conviction in D-PLEX₁₀₀'s potential to address a significant unmet medical need."
"Moreover, we are extremely encouraged by the enthusiastic reception from healthcare professionals who recognize the potential of D-PLEX₁₀₀ to substantially reduce the burden of SSIs, improve patient outcomes, and generate meaningful healthcare cost savings," continued Ms. Czaczkes Akselbrad. "With our strengthened balance sheet and multiple strategic options before us, we are well-positioned to maximize the value of our innovative technology."
Financial results for three months ended June 30, 2025
- R&D expenses for the three months ended June 30, 2025, were
$6.2 million , compared to$4.8 million in the same three-month period of 2024. The increase in R&D expenses was primarily due to activities related to the completion of the SHIELD II Phase 3 trial and preparation for regulatory submissions. - General and administrative (G&A) expenses for the three months ended June 30, 2025, were
$2.5 million , compared to$1.1 million for the same period of 2024. The increase was primarily due to non-cash expenses related to performance-based options (PSUs), following the successful SHIELD II Phase 3 trial, which triggered the vesting of the PSUs. - Marketing and business development expenses for the three months ended June 30, 2025, were
$0.7 million , compared to$0.3 million for the same period of 2024. The increase was primarily due to non-cash expenses related to PSUs, following the successful SHIELD II Phase 3 trial, which triggered the vesting of the PSUs. - For the three months ended June 30, 2025, the Company had a net loss of
$10.0 million , or ($0.78) per share, compared to a net loss of$6.3 million , or ($1.25) per share, in the three-month period ended June 30, 2024.
Financial results for six months ended June 30, 2025
- R&D expenses for the six months ended June 30, 2025, were
$12.3 million , compared to$9.8 million for the same six-month period of 2024. The increase in R&D expenses was primarily due to activities related to the completion of the SHIELD II Phase 3 trial and preparation for regulatory submissions. - G&A expenses for the six months ended June 30, 2025, were
$3.7 million , compared to$2.1 million for the same period of 2024. The increase was primarily due to non-cash expenses related to PSUs, following the successful SHIELD II Phase 3 trial, which triggered the vesting of the PSUs. - Marketing and business development expenses for the six months ended June 30, 2025, were
$1.0 million , compared to$0.5 million for the same period of 2024. The increase was primarily due to non-cash expenses related to PSUs, following the successful SHIELD II Phase 3 trial, which triggered the vesting of the PSUs. - For the six months ended June 30, 2025, the Company had a net loss of
$18.2 million , or ($1.48) per share, compared to a net loss of$12.7 million , or ($2.62) per share, in the six-month period ended June 30, 2024.
Balance Sheet Highlights
- As of June 30, 2025, the Company had cash and cash equivalents and short-term deposits in the amount of
$29.5 million , compared to$15.6 million on December 31, 2024. PolyPid expects that its current cash balance will be sufficient to fund operations well into 2026.
Conference Call Dial-In & Webcast Information:
ٲٱ: | Wednesday, August 13, 2025 |
Time: | 8:30 AM Eastern Time |
Conference Call: | |
Webcast: | |
AboutPolyPid
PolyPid Ltd.(Nasdaq:) is a late-stage biopharma company aiming to improve surgical outcomes. Through locally administered, controlled, prolonged-release therapeutics, PolyPid's proprietary PLEX (Polymer-Lipid Encapsulation matriX) technology pairs with Active Pharmaceutical Ingredients (APIs), enabling precise delivery of drugs at optimal release rates over durations ranging from several days to months. Following positive phase 3 results, New Drug Application (NDA) submission of D-PLEX₁₀₀, PolyPid's lead product candidate, for the prevention of abdominal colorectal surgical site infections, is expected in early 2026. In addition, the Company has an innovative pipeline in oncology, obesity and diabetes.
For additional Company information, please visitand follow us onand.
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 D-PLEX₁₀₀'s potential clinical benefits, the expected NDA submission and its timing, its commercialization preparations and strategic partnership discussions to maximize D-PLEX₁₀₀'s market potential, the aims of GLP-1 program, the Company's potential commercial partners, D-PLEX₁₀₀'s potential to address a significant unmet medical need, the Company's ability to maximize the value of its innovative technology and the Company's expectation that its current cash runway will be sufficient well into 2026. 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 26, 2025. 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
Investor & IR Contact:
Arx | Capital Markets
North American Equities Desk
INTERIM CONDENSED CONSOLIDATED BALANCE SHEETS (UNAUDITED) | |||||
U.S.dollars in thousands | |||||
June 30, | December 31, | ||||
2025 | 2024 | ||||
ASSETS | |||||
CURRENT ASSETS: | |||||
Cash and cash equivalents | $ | 17,448 | $ | 15,641 | |
Restricted deposits | 182 | 168 | |||
Short-term deposits | 12,007 | - | |||
Prepaid expenses and other current assets | 351 | 764 | |||
Total current assets | 29,988 | 16,573 | |||
LONG-TERM ASSETS: | |||||
Property and equipment, net | 5,339 | 6,075 | |||
Operating lease right-of-use assets | 2,062 | 2,295 | |||
Other long-term assets | 298 | 277 | |||
Total long-term assets | 7,699 | 8,647 | |||
Total assets | $ | 37,687 | $ | 25,220 | |
INTERIM CONDENSED CONSOLIDATED BALANCE SHEETS (UNAUDITED) | |||||||
U.S. dollars in thousands (except share and per share data) | |||||||
June 30, | December 31, | ||||||
2025 | 2024 | ||||||
LIABILITIES AND SHAREHOLDERS' EQUITY | |||||||
CURRENT LIABILITIES: | |||||||
Trade payables | $ | 2,572 | $ | 2,409 | |||
Accrued expenses and other current liabilities | 2,967 | 2,566 | |||||
Current maturities of long-term debt | 6,548 | 6,787 | |||||
Current maturities of operating lease liabilities | 1,068 | 919 | |||||
Total current liabilities | 13,155 | 12,681 | |||||
LONG-TERM LIABILITIES: | |||||||
Long-term debt | - | 634 | |||||
Deferred revenues | 2,548 | 2,548 | |||||
Long-term operating lease liabilities | 1,054 | 1,277 | |||||
Other liabilities | 454 | 396 | |||||
Total long-term liabilities | 4,056 | 4,855 | |||||
COMMITMENTS AND CONTINGENT LIABILITIES | |||||||
SHAREHOLDERS' EQUITY: | |||||||
Ordinary shares with no par value - | |||||||
Authorized: 107,800,000 shares at June 30, 2025 and December 31, 2024; Issued and outstanding: 15,654,129 and 10,190,904 shares at June 30, 2025 and December 31, 2024, respectively | |||||||
Additional paid-in capital | 306,052 | 275,015 | |||||
Accumulated deficit | (285,576 | ) | (267,331 | ) | |||
Total shareholders' equity | 20,476 | 7,684 | |||||
Total liabilities and shareholders' equity | $ | 37,687 | $ | 25,220 | |||
INTERIM CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (UNAUDITED) | |||||||||||
U.S. dollars in thousands (except share and per share data) | |||||||||||
Six Months Ended | Three Months Ended | ||||||||||
June 30, | June 30, | ||||||||||
2025 | 2024 | 2025 | 2024 | ||||||||
Operating expenses: | |||||||||||
Research and development | $ | 12,332 | $ | 9,810 | $ | 6,215 | $ | 4,760 | |||
Marketing and business development | 989 | 501 | 700 | 265 | |||||||
General and administrative | 3,661 | 2,111 | 2,488 | 1,096 | |||||||
Operating loss | 16,982 | 12,422 | 9,403 | 6,121 | |||||||
Loss on extinguishment of debt | 512 | - | - | - | |||||||
Financial expenses, net | 687 | 311 | 521 | 171 | |||||||
Loss before income tax | 18,181 | 12,733 | 9,924 | 6,292 | |||||||
Income tax expenses | 64 | 9 | 53 | 2 | |||||||
Net loss | $ | 18,245 | $ | 12,742 | $ | 9,977 | $ | 6,294 | |||
Loss per share: | |||||||||||
Basic and diluted | $ | 1.48 | $ | 2.62 | $ | 0.78 | $ | 1.25 | |||
Weighted-average Ordinary shares outstanding: | |||||||||||
Basic and diluted | 12,298,113 | 4,858,158 | 12,841,621 | 5,024,871 | |||||||
