PolyPid
Market cap $125M 20.3M shares (vendor count, Nov 7, 2026) × $6.14 close Nov 6, 2026 · share count from the market-data vendor, not the SEC cover page
Most recent annual filing: 2026-02-25
- D-PLEX₁₀₀ filing2H 2026D-PLEX₁₀₀ filing, 2H 2026, notable
- D-PLEX₁₀₀ PDUFA dateNov 28, 2026D-PLEX₁₀₀ PDUFA date, Nov 28, 2026, thesis-defining
- D-PLEX₁₀₀ commercial launch1Q 2027D-PLEX₁₀₀ commercial launch, 1Q 2027, routine
- D-PLEX₁₀₀ EU decision2H 2027D-PLEX₁₀₀ EU decision, 2H 2027, material
Bar width shows how precise the guidance is — a pin is a stated date, a wide band a six-month window. Deeper blue means more of the thesis rides on the event; it is not a view on the stock.
Pipeline (3 active programs)
Technology platforms
PLEX · ImmunoGenesis
Proprietary polymer-lipid matrix controlled-release delivery platform enabling localized, prolonged drug release at the target site over days to months; applicable to small molecules, peptides, antibodies, and nucleic acid-based drugs; disease areas include surgical site infection prevention, oncology, inflammation, and pain.
Kynatrix
Controlled-release drug delivery technology pairing with active pharmaceutical ingredients to enable prolonged, localized antibiotic release at the site of care; applied in surgical infection prevention (D-PLEX100) and being extended to infection treatment (PD01B for diabetic foot infections)
Targets: GLP-1 receptor
Capital (as filed)
- Cash
- $6.4M cash and cash equivalents · Dec 31, 2025 (20-F)
- Operating cash flow
- −$7.0M annual ÷ 4, year to Dec 31, 2025 (20-F)
- As stated in coverage
- $6.6M cash, runway 2028 per the update of Aug 12, 2026 — the company's own words as read there, not the filed figure
Cash, investments and operating cash flow are the company's own XBRL facts as filed with the SEC, each shown with its period end and tag. As-stated figures come from the company's own words as read in Biotech Distilled coverage, dated, and routinely count securities and planned financing that a balance sheet does not. Offering rows are the SEC cover pages as filed. Not investment advice. Figures as of Nov 7, 2026.
Biotech Distilled coverage (4)
- 2026-10-22 UPDATE: PolyPid (PYPD) - The Stewardship Receipt 🔒 Paid
- 2026-10-02 UPDATE: PolyPid (PYPD) - Europe Comes Home 🔒 Paid
- 2026-08-13 UPDATE: PolyPid (PYPD) - The Going-Concern Paragraph Is Gone 🔒 Paid
- 2026-08-03 PolyPid Ltd. (PYPD) — Scientific Deep Dive for D-PLEX₁₀₀ and the Kynatrix Platform 🔒 Paid
Articles open on Substack. Some are subscriber-only; those marked ★ Distilled Pro are for Distilled Pro members.
Verdict history (4 calls)
Every verdict Biotech Distilled has published on PolyPid, oldest first — the full history, never a selection. How calls are scored: the track record.
- 2026-08-03 Watch PolyPid Ltd. (PYPD) — Scientific Deep Dive for D-PLEX₁₀₀ and the Kynatrix Platform Science replicated and balance sheet funded through the binary, but manufacturing inspection risk and label breadth are unresolved and unpriced, while the only two informed buyers committed under $33M cash for rights the market values at four times that.
- 2026-08-13 Speculative buy speculative UPDATE: PolyPid (PYPD) - The Going-Concern Paragraph Is Gone Going-concern language removed, runway guided into 2028, and mid-teen to mid-twenties royalty economics now disclosed in a filing, retiring the financing failure mode while the manufacturing inspection and label breadth remain the unhedgeable binary risks.
- 2026-10-02 Speculative buy speculative UPDATE: PolyPid (PYPD) - Europe Comes Home Advanz termination adds European re-licensing optionality without raising the burden, but the FDA manufacturing inspection remains unhedgeable and the November 28 binary is unchanged.
- 2026-10-22 Speculative buy speculative UPDATE: PolyPid (PYPD) - The Stewardship Receipt Pooled microbiology data showing no resistance enrichment modestly helps the commercial stewardship case but does not de-risk the manufacturing inspection or resolve label breadth ahead of the November 28 PDUFA.
- Long call · opened Aug 13, 2026 at $4.78 · +28.5% vs XBI -3.0% (Nov 6, 2026)
Every verdict Biotech Distilled has published on this company, in order, with the post it came from — the full history, never a selection. Position figures are the same ones shown on /track-record, computed by the same method. Editorial opinion, not investment advice.
Timing, in the company's words (2 quotes from 2 filings)
Sentences quoted verbatim from the company's SEC filings, newest filing first. Each sits under the filing it appeared in; the "matched to" tag names the calendar row it was read for.
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“PolyPid’s management will also review the Company’s plans to maximize the value of D-PLEX₁₀₀, for which a New Drug Application (“NDA”) is under FDA Priority Review with a PDUFA goal date of November 28, 2026, including potential label expansion beyond colorectal surgery and potential geographic expansion.”
matched to D-PLEX₁₀₀ · regulatory decision · read as November 28, 2026
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“The U.S. Food and Drug Administration (“FDA”) has accepted PolyPid’s NDA for D-PLEX₁₀₀ and granted Priority Review, with a Prescription Drug User Fee Act (“PDUFA”) goal date of November 28, 2026.”
matched to D-PLEX₁₀₀ · regulatory decision · read as November 28, 2026
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Timing sentences quoted from the company's own SEC filings, each under the filing it appeared in. The 'matched to' tag is the calendar row the sentence was read for; the filing is the source. Not investment advice.
Filings & releases (20)
SEC filings from EDGAR and press releases captured from the company's investor-relations site, newest first. Releases captured from Aug 12, 2026; filings from March 2026. Summaries come from the BD update that read the document; "BD extracted" counts point at the pipeline table above. All companies →
- Oct 29, 2026ReleasePolyPid to Report Third Quarter 2026 Financial Results and Operational Highlights on November 11, 2026
- Oct 28, 2026ReleasePolyPid Unveils Expanded Pipeline Strategy, Introducing PD01B, a New Kynatrix™ Based Product Candidate for the Treatment of Diabetic Foot InfectionsSummary on the 6-KBD extracted 1 program update from this document → PYPD pipeline
- Oct 28, 20266-KForeign issuer report · EX-99.1 PRESS RELEASE ISSUED BY POLYPID LTD. ON OCTOBER 28, 2026, TITLED "POLYPID UNVEILThirty-one days before the November 28 PDUFA, PolyPid named PD01B — a Kynatrix-based local antibiotic for diabetic foot infections — and updated its catalyst table with the first hard NTAP timing (August 2027) and a new label-expansion FDA dialogue starting Q4 2026. None of this moves the manufacturing-inspection needle, but the platform is now more than a one-product story, and the NTAP date update corrects one of the bear-case assumptions I laid out.
- Oct 21, 2026ReleasePolyPid to Present D-PLEX₁₀₀ Microbiology Data at IDWeek 2026→ BD updateFive weeks before the November 28 PDUFA, PolyPid drops the microbiology data I said was missing — pooled across 2,185 patients, it shows lower bacterial burden in breakthrough SSIs and no evidence of resistance selection, directly answering the antimicrobial stewardship objection that was the biggest adoption-tax risk nobody was modeling.BD extracted 1 program update from this document → PYPD pipeline
- Oct 15, 2026ReleasePolyPid to Host Virtual Investor Day on Wednesday, October 28, 2026BD extracted 1 program update from this document → PYPD pipeline
- Oct 1, 2026ReleaseEuropean Medicines Agency Validates PolyPid’s Marketing Authorization Application for D-PLEX₁₀₀→ BD updateSummary on the 6-K
- Oct 1, 2026ReleasePolyPid Regains European Commercialization Rights for D-PLEX₁₀₀, Expanding Global Commercialization Opportunities→ BD updateSummary on the 6-K
- Oct 1, 20266-KForeign issuer report · EX-99.1 PRESS RELEASE ISSUED BY POLYPID LTD. ON OCTOBER 1, 2026, TITLED "EUROPEAN MEDICI→ BD updateAdvanz is out and PolyPid owns Europe again — the partnership I called a "cautionary tale" (€2.5M in, zero milestones earned in four years) has been mutually terminated, simultaneously with EMA validating the MAA for formal CHMP review. The European commercial picture just changed materially, eight weeks before the U.S. PDUFA.BD extracted 1 program update from this document → PYPD pipeline
- Oct 1, 20266-KForeign issuer report · EX-99.1 PRESS RELEASE ISSUED BY POLYPID LTD. ON OCTOBER 1, 2026, TITLED "POLYPID REGAINS→ BD updateSummary on the 6-K
- Sep 15, 2026ReleasePolyPid Announces Participation in Upcoming Fall Investor Conferences
- Aug 12, 2026ReleasePolyPid Provides Corporate Update and Reports Second Quarter 2026 Financial ResultsBD extracted 2 program updates from this document → PYPD pipeline
- Aug 12, 20266-KForeign issuer report · EX-99.1 POLYPID LTD.'S INTERIM CONDENSED FINANCIAL STATEMENTS AS OF JUNE 30, 2026
- Aug 12, 20266-KForeign issuer report · EX-99.1 PRESS RELEASE ISSUED BY POLYPID LTD. ON AUGUST 12, 2026, TITLED "POLYPID PROVIDE
- Jul 29, 20266-KForeign issuer report · EX-99.1 PRESS RELEASE ISSUED BY POLYPID LTD. ON JULY 29, 2026, TITLED "POLYPID ANNOUNCES
- Jul 21, 20266-KForeign issuer report · EX-99.1 PRESS RELEASE ISSUED BY POLYPID LTD. ON JULY 21, 2026, TITLED "POLYPID ANNOUNCES
- Jul 15, 20266-KForeign issuer report · EX-99.1 AMENDED AND RESTATED 2012 SHARE OPTION PLAN
- Jun 10, 20266-KForeign issuer report · EX-99.1 NOTICE FOR THE ANNUAL AND EXTRAORDINARY GENERAL MEETING TO BE HELD ON JULY 15, 2
- Jun 1, 20266-KForeign issuer report · EX-99.1 PRESS RELEASE ISSUED BY POLYPID LTD. ON JUNE 1, 2026, TITLED "POLYPID COMPLETES
- May 13, 20266-KForeign issuer report · EX-99.1 PRESS RELEASE ISSUED BY POLYPID LTD. ON MAY 13, 2026, TITLED "POLYPID PROVIDES C
- Mar 31, 20266-KForeign issuer report · EX-99.1 PRESS RELEASE ISSUED BY POLYPID LTD. ON MARCH 31, 2026, TITLED "POLYPID INITIATE
5 more filings (13G holder notices, S-8, proxy material, SEC correspondence …)
- Aug 13, 2026SCHEDULE 13G/A13G amendment
- Aug 12, 2026SCHEDULE 13G/A13G amendment
- Aug 12, 2026S-8Employee plan registration
- May 12, 2026SCHEDULE 13G/A13G amendment
- May 4, 2026SCHEDULE 13G/A13G amendment