PolyPid Ltd. (PYPD): History, Ownership, Mission, How It Works & Makes Money

How does a late-stage biopharma company, PolyPid Ltd., balance a nine-month net loss of $25.7 million with the immense market potential of its lead product, D-PLEX₁₀₀? You are looking at a critical inflection point for a company whose proprietary Polymer-Lipid Encapsulation matriX (PLEX) technology is on track for a New Drug Application (NDA) submission in early 2026, aiming to finally solve the problem of surgical site infections.

With a cash position of $18.8 million as of September 30, 2025, and strategic partnership discussions advancing quickly after positive Phase 3 results, PolyPid Ltd. is defintely a high-stakes play in the surgical outcomes space, but is its technology truly a game-changer for localized drug delivery?

PolyPid Ltd. (PYPD) History

You need a clear picture of how PolyPid Ltd. got to where it is today-a late-stage biopharma company on the cusp of a major regulatory filing. The story is one of persistent development of a core drug-delivery technology, the Polymer-Lipid Encapsulation matriX (PLEX), which has been the singular focus since its founding. That focus is now paying off with their lead product, D-PLEX100, which is nearing a New Drug Application (NDA) submission.

Given Company's Founding Timeline

Year established

PolyPid Ltd. was incorporated in the State of Israel in 2008, with a clear mission to improve surgical outcomes through localized drug delivery.

Original location

The company is headquartered in Petach Tikva, Israel, with its fully owned U.S. subsidiary, PolyPid Inc., located in Summit, New Jersey.

Founding team members

The company was founded by Dr. Noam Emanuel on February 28, 2008, who initially served as the Chief Technology Officer.

Initial capital/funding

The earliest public funding was a first round of financing in 2010, which raised $1.4 million from private investors. This was followed by a second round in 2012, raising an additional $2 million at a post-money valuation of $10 million.

Given Company's Evolution Milestones

Given Company's Transformative Moments

The company's trajectory has been defined by two major pivots: proving the PLEX technology's clinical efficacy and securing the capital to commercialize it.

• Validating PLEX Technology: The successful topline results from the Phase 3 SHIELD II trial in mid-2025 were defintely a game-changer. This positive data is what transforms PolyPid from a clinical-stage company into a commercial-stage one, shifting the focus from R&D expense-which totaled $17.6 million for the first nine months of 2025-to marketing and regulatory submission.
• Securing Late-Stage Capital: Following the positive Phase 3 results, the company secured $26.7 million in additional funding in June 2025 through the exercise of warrants. This funding extended their cash runway well into 2026, which is crucial for funding the New Drug Application (NDA) submission to the FDA, expected in early 2026. This is the quick math on bridging the gap.
• The Regulatory Sprint: The scheduled face-to-face pre-NDA meeting with the FDA in early December 2025 is the final, high-stakes step before the formal submission. This meeting will align the company's data package with the agency's requirements, making the NDA submission a near-certainty, assuming the meeting goes well.

The net loss for the first nine months of 2025 was $25.7 million, which shows the high cost of running a late-stage trial and preparing for commercialization. The company's financial health hinges entirely on the successful NDA and securing a U.S. partnership for D-PLEX100. You can dig deeper into the numbers by reading Breaking Down PolyPid Ltd. (PYPD) Financial Health: Key Insights for Investors.

PolyPid Ltd. (PYPD) Ownership Structure

PolyPid Ltd. (PYPD) operates as a publicly traded company on the Nasdaq Capital Market, meaning its ownership is distributed among a diverse group of institutional investors, company insiders, and the general public. This structure ensures a degree of market transparency and liquidity, but it also means strategic decisions are subject to the interests of a significant institutional shareholder base.

Given Company's Current Status

PolyPid Ltd. is a late-stage biopharma company, publicly listed on the Nasdaq Capital Market under the ticker PYPD. This status subjects the company to rigorous reporting requirements by the U.S. Securities and Exchange Commission (SEC), offering investors a clear view into its operations and financial health.

As of November 2025, the company's market capitalization stands at approximately $56.91 million, reflecting its valuation as a clinical-stage firm focused on its proprietary PLEX (Polymer-Lipid Encapsulation matriX) technology. The total number of issued and outstanding shares was 16,634,790 as of September 30, 2025. Honestly, for a biotech firm, having a strong institutional base is defintely a key sign of confidence in the pipeline, even with the inherent volatility.

Given Company's Ownership Breakdown

The company's ownership is governed by a split between large professional money managers, the executive team and board, and individual investors. Institutional investors hold the largest block of shares, which often translates to greater influence in shareholder votes and corporate governance matters.

Here's the quick math on the ownership distribution as of November 2025, based on the latest SEC filings:

For a deeper dive into the major institutional holders and their recent trading activity, you should check out Exploring PolyPid Ltd. (PYPD) Investor Profile: Who's Buying and Why?

Given Company's Leadership

The company is steered by a seasoned executive team with deep roots in the pharmaceutical and life sciences sectors, focusing heavily on clinical development and regulatory strategy. The average tenure of the management team is around 3.3 years.

The key leaders, as of November 2025, are:

• Dikla Czaczkes Akselbrad: Chief Executive Officer (CEO) and Director. She has over two decades of experience in life sciences and led the company's 2020 Nasdaq IPO.
• Jonny Missulawin: Chief Financial Officer (CFO). He brings over 10 years of experience in financial operations within the Hi-Tech and biotechnology industries.
• Dalit Hazan: Deputy CEO, Executive Vice President (EVP) of R&D, Clinical, and Regulatory Affairs. She has over 25 years of expertise in regulatory affairs and drug development.
• Ori Warshavsky: Chief Operating Officer - US. He focuses on US-market strategy, commercialization, and market access.
• Nir Dror: Interim Chairman of the Board. He was elected to this role in August 2025, after serving as a director since May 2020.

The leadership's immediate focus, as highlighted in the Q3 2025 earnings report, is on the upcoming pre-New Drug Application (NDA) meeting with the FDA in early December 2025 and the planned NDA submission for D-PLEX$_{100}$ in early 2026.

PolyPid Ltd. (PYPD) Mission and Values

PolyPid Ltd.'s core purpose is clear: to fundamentally change surgical outcomes by delivering drugs precisely and locally over a prolonged period, moving beyond the traditional systemic (whole-body) antibiotic approach. This mission is backed by a financial reality that saw a net loss of $7.5 million in the third quarter of 2025, which is the cost of advancing a potentially transformative drug like D-PLEX₁₀₀ toward market.

Given Company's Core Purpose

You need to look past the boilerplate to see what drives a late-stage biopharma company like PolyPid Ltd. Their mission isn't just about a drug; it's about a delivery system-the Polymer-Lipid Encapsulation matriX (PLEX) technology-that can tackle complex, localized medical issues like infection and cancer.

Official Mission Statement

The company's mission is to improve surgical outcomes through locally administered, controlled, and prolonged-release therapeutics. This is not some vague corporate filler; it's a tangible goal tied directly to their lead product, D-PLEX₁₀₀, which is designed to prevent surgical site infections (SSIs) in high-risk procedures like abdominal colorectal surgery.

The core of this mission is the PLEX technology, which:

• Pairs with Active Pharmaceutical Ingredients (APIs).
• Enables drug delivery over a period of several days to months.
• Aims to lower the overall cost of treatment.

Here's the quick math on the impact: the Phase 3 SHIELD II trial showed D-PLEX₁₀₀ achieved a statistically significant reduction of 38% in the primary endpoint (SSIs, all-cause mortality, and reintervention), with a p-value below 0.005. That's a defintely compelling clinical result.

Vision Statement

PolyPid Ltd.'s vision is to establish its PLEX technology as a paradigm shift in the treatment of various localized medical conditions. They are not stopping at surgical infections; they are actively working on an innovative pipeline that includes preclinical stages for solid tumors (OncoPLEX) and novel long-acting delivery platforms for conditions like obesity and diabetes.

The near-term vision is highly focused on commercialization. They are on track to submit a New Drug Application (NDA) for D-PLEX₁₀₀ to the U.S. Food and Drug Administration (FDA) in early 2026, leveraging their Fast Track and Breakthrough Therapy designations. This is the critical next step. You can see how institutional investors are viewing this in Exploring PolyPid Ltd. (PYPD) Investor Profile: Who's Buying and Why?

Given Company Slogan/Tagline

While PolyPid Ltd. doesn't use a formal, consumer-facing tagline, their operational slogan, often used in corporate communications, is centered on the technology's benefit: 'Controlled, Prolonged-Release Therapeutics.' This phrase encapsulates the value proposition for surgeons and hospital administrators.

The financial runway supports this aggressive vision. As of September 30, 2025, PolyPid Ltd. had $18.8 million in cash, cash equivalents, and short-term deposits, which is expected to fund operations well into 2026. The projected annual revenue for 2025, based on analyst forecasts, is around $55 million, underscoring the potential market size they are targeting with D-PLEX₁₀₀.

PolyPid Ltd. (PYPD) How It Works

PolyPid Ltd. operates as a late-stage biopharmaceutical company focused on significantly improving surgical outcomes by preventing infections right at the surgical site. The company's core value proposition is its proprietary Polymer-Lipid Encapsulation matriX (PLEX) technology, which acts as a controlled-release delivery system for active pharmaceutical ingredients (APIs).

This technology allows a drug, like an antibiotic, to be administered once during surgery and then released locally and continuously over an extended period-ranging from several days to months-ensuring a high local concentration to fight infection without the systemic side effects of oral or intravenous drugs.

PolyPid Ltd.'s Product/Service Portfolio

As of November 2025, PolyPid's portfolio is primarily anchored by its lead product candidate, D-PLEX$_{100}$, with a pipeline of other PLEX-based candidates advancing through earlier stages.

PolyPid Ltd.'s Operational Framework

You need to understand that PolyPid's operational focus right now isn't about selling product; it's about regulatory clearance and commercial readiness for D-PLEX$_{100}$. The company makes money by raising capital and, eventually, will generate revenue through product sales or partnership deals.

• Value Creation: The core process is the PLEX technology development, which encapsulates an Active Pharmaceutical Ingredient (API) within a polymer-lipid matrix for controlled release. This unique delivery method is the entire basis of their product pipeline.
• Regulatory Advancement: The company is on track for a face-to-face pre-New Drug Application (pre-NDA) meeting with the U.S. Food and Drug Administration (FDA) in early December 2025, with the goal of submitting the D-PLEX$_{100}$ NDA in early 2026.
• Manufacturing and Quality: PolyPid is advancing its commercial manufacturing readiness, having completed a successful Good Manufacturing Practice (GMP) inspection by the Israeli Ministry of Health in 2025.
• Financial Burn: For the nine months ended September 30, 2025, the company reported a net loss of $25.7 million, with Research and Development (R&D) expenses at $17.6 million, largely driven by the completion of the SHIELD II Phase 3 trial.
• Cash Position: The company ended the third quarter of 2025 (Q3 2025) with a cash and cash equivalents balance of $18.8 million, which they expect will fund operations well into 2026. Honestly, that cash runway is defintely a critical metric.

To get a deeper look at the financials, check out: Breaking Down PolyPid Ltd. (PYPD) Financial Health: Key Insights for Investors

PolyPid Ltd.'s Strategic Advantages

PolyPid's market success hinges on its technology and the regulatory status of D-PLEX$_{100}$.

• Proprietary PLEX Technology: This platform is the foundation, enabling a single, local administration of a drug to achieve therapeutic concentrations for weeks, which is a significant advantage over repeated systemic doses.
• Positive Pivotal Phase 3 Data: The successful SHIELD II trial demonstrated a statistically significant reduction of 38% in the primary endpoint (a composite of SSIs, mortality, and reintervention) and a 58% reduction in SSI rates alone with D-PLEX$_{100}$ versus standard of care.
• Key Regulatory Designations: D-PLEX$_{100}$ holds both Fast Track and Breakthrough Therapy designations from the FDA, which should expedite the review process and is a strong signal of unmet clinical need.
• Targeting a Massive Unmet Need: Surgical site infections are a major burden on healthcare systems. D-PLEX$_{100}$ is targeting a substantial U.S. market of over 12 million annual surgeries, offering a solution that could significantly lower hospital costs and patient morbidity.
• Commercial Momentum: Following the positive Phase 3 results in June 2025, the company is actively engaged in strategic partnership and due diligence discussions with potential U.S. partners for commercialization.

PolyPid Ltd. (PYPD) How It Makes Money

As a late-stage biopharmaceutical company, PolyPid Ltd. currently generates effectively zero product revenue and primarily funds its operations through equity financing, debt, and the exercise of warrants, essentially operating on its balance sheet to advance its lead candidate, D-PLEX ${ }^{\text {TM }}$ 100, toward commercialization. The company's future financial engine is entirely dependent on the successful regulatory approval and subsequent commercial sales or partnership licensing of its proprietary PLEX (Polymer-Lipid Encapsulation matriX) drug delivery technology.

PolyPid Ltd.'s Revenue Breakdown

You need to understand that PolyPid Ltd. is a pre-commercial business, meaning it has no revenue from product sales as of November 2025. The company's financial results for the nine months ended September 30, 2025, show that reported revenue is essentially non-existent, which is typical for a company awaiting New Drug Application (NDA) approval for its lead asset, D-PLEX ${ }^{\text {TM }}$ 100. The revenue model is 100% aspirational right now.

Business Economics

The core economics of PolyPid Ltd. are currently defined by its burn rate-how fast it spends its cash on research and development (R&D) to get D-PLEX ${ }^{\text {TM }}$ 100 approved-rather than a gross margin on sales. The goal is to transition from a high-cost R&D model to a high-margin specialty pharmaceutical model.

• Cost Structure: The vast majority of costs are R&D and administrative expenses, not Cost of Goods Sold (COGS). For the nine months ended September 30, 2025, R&D expenses were $17.6 million, reflecting the cost of completing the Phase 3 SHIELD II trial and preparing for regulatory submissions.
• Pricing Strategy: The future pricing for D-PLEX ${ }^{\text {TM }}$ 100 will likely be premium, typical for an innovative, locally administered antibiotic that significantly reduces the incidence of surgical site infections (SSIs), a major cost driver for hospitals. A new U.S. market access study shows strong interest from surgeons and hospital pharmacy directors, which validates the commercial potential.
• Market Opportunity: Analyst projections for PolyPid Ltd.'s annual revenue, once D-PLEX ${ }^{\text {TM }}$ 100 is approved and launched, have been cited as high as $55 million. This is the prize the current spending is chasing.
• Cash Runway: The company strengthened its balance sheet by securing $26.7 million in additional funding through warrant exercises in June 2025, extending its cash runway well into 2026, beyond the anticipated NDA approval. That's the lifeblood of a pre-revenue biotech.

PolyPid Ltd.'s Financial Performance

The financial performance data for the 2025 fiscal year, specifically the nine months ended September 30, 2025, highlights a company fully dedicated to its final regulatory push, which means high expenses and a growing net loss.

• Net Loss: The net loss for the nine months ended September 30, 2025, was $25.7 million, an increase from the $20.5 million loss in the same period in 2024. This increase is a direct result of the ramp-up in regulatory and commercial readiness activities.
• Operating Expenses: Total operating expenses are rising as the company transitions from a clinical-stage to a commercial-ready entity. General and administrative (G&A) expenses for the nine months ended September 30, 2025, increased to $5.4 million, up from $3.3 million in the prior year period. Honestly, you want to see G&A controlled, but a jump in marketing expenses (up to $1.4 million for the nine months) is defintely expected as commercial preparations advance.
• Balance Sheet Health: As of September 30, 2025, the company reported cash, cash equivalents, and short-term deposits of $18.8 million. This cash position is critical for funding operations until D-PLEX ${ }^{\text {TM }}$ 100 can generate revenue or a partnership deal is secured.

To get a deeper look at how the company's balance sheet supports this transition, you should check out Breaking Down PolyPid Ltd. (PYPD) Financial Health: Key Insights for Investors.

PolyPid Ltd. (PYPD) Market Position & Future Outlook

PolyPid Ltd. is a late-stage biopharma company transitioning from a research-heavy profile to a commercial-readiness model, anchored by its lead product, D-PLEX₁₀₀. The company's market position as of November 2025 is defined by its pre-revenue status-with an estimated $0 in revenue for the 2025 fiscal year-and the substantial clinical validation of its proprietary PLEX (Polymer-Lipid Encapsulation matriX) technology. The future outlook hinges on a successful New Drug Application (NDA) submission for D-PLEX₁₀₀ in early 2026, targeting the $10 billion U.S. surgical site infection (SSI) prevention market opportunity. That's the entire game right now.

Competitive Landscape

The competitive landscape for D-PLEX₁₀₀ is not a direct fight against another localized, prolonged-release antibiotic, but a battle for inclusion in the existing standard of care (SoC) bundle. The current SSI prevention market is dominated by large, diversified medical device and pharmaceutical companies whose products-like antiseptic solutions, surgical drapes, and antimicrobial sutures-form the existing SoC.

Here's the quick math: PolyPid's 0% market share reflects its pre-commercial status, while the estimated shares for competitors represent their established presence in the overall $5.99 billion Surgical Site Infection Control Market in 2025. D-PLEX₁₀₀ aims to be an additive therapy, not a replacement for these players' core products, which makes its commercial strategy unique.

Opportunities & Challenges

You're looking at a classic binary biotech scenario: massive upside potential against a high regulatory and commercial execution risk. The company's nine-month net loss of $25.7 million through September 30, 2025, shows the cost of pursuing this high-stakes opportunity. For a deeper dive into the financials, you should read Breaking Down PolyPid Ltd. (PYPD) Financial Health: Key Insights for Investors.

Industry Position

PolyPid Ltd. is currently a technology leader in the niche of localized, prolonged-release drug delivery for SSI prevention, but it remains a small, late-stage clinical entity. Its position is defined by the PLEX platform, which offers a 30-day controlled release of the antibiotic doxycycline directly at the surgical site, a critical advantage over the short duration of systemic antibiotics. This platform is defintely a game-changer if approved.

• Technology Differentiation: The PLEX platform's ability to provide a high local concentration of antibiotics for up to 30 days addresses the post-operative window where most SSIs occur, a clear gap in the current SoC.
• Regulatory Advantage: D-PLEX₁₀₀ holds Fast Track and Breakthrough Therapy designations, which should expedite the FDA review process following the early 2026 NDA submission.
• Financial Runway: The company's cash balance of $18.8 million as of September 30, 2025, is expected to fund operations well into 2026, covering the critical period leading up to and past the NDA submission.

The next step is simple: watch for the announcement of a definitive U.S. commercial partnership, as that deal will be the most significant near-term catalyst for market adoption.