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PolyPid 2030 Investor DayOctober 20261
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Forward-Looking Statement 2 This presentation contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act and other federal securities laws. For example, the Company is using forward-looking statements when it discusses the U.S. Food and Drug Administration’s (“FDA”) review of the New Drug Application (“NDA”) for D-PLEX₁₀₀, including the Priority Review designation and the Prescription Drug User Fee Act (“PDUFA”) goal date of November 28, 2026; possible label expansion beyond colorectal surgery, the FDA pre-approval inspection of the Company’s manufacturing facility; the potential approval of D-PLEX₁₀₀; and the expected commercial launch of D-PLEX₁₀₀ by Azurity Pharmaceuticals (“Azurity”) in the United States in early 2027.Forward-looking statements also include the Company’s exclusive commercialization partnership with Azurity for the United States and Canada, including the partnership’s economic structure, potential milestone payments, tiered royalties and transfer price, and the joint development activities and label expansion programs contemplated under that agreement; potential reimbursement for D-PLEX₁₀₀, including New Technology Add-on Payment (“NTAP”) status; the European Medicines Agency’s (“EMA”) review of the Marketing Authorization Application for D-PLEX₁₀₀ and the anticipated timing of that review; the Company’s plans for the commercialization of D-PLEX₁₀₀ in Europe and other territories following the reversion of European rights from ADVANZ PHARMA, including potential partnerships; the design, development plan, regulatory pathway, and anticipated timing of the Investigational New Drug application and clinical trials for PD01B, and its potential benefits; the Company’s Kynatrix technology and other pipeline programs, including its long-acting metabolic program; and the Company’s growth strategy and expected milestones through 2030.Words such as “expects,” “anticipates,” “intends,” “plans,” “believes,” “seeks,” “estimates” and similar expressions are intended to identify forward-looking statements. Forward-looking statements are not historical facts and are based upon management’s current expectations, beliefs and projections, many of which are inherently uncertain and beyond the Company’s control. Actual results may differ materially from those expressed in or implied by the forward-looking statements. For a more detailed description of the risks and uncertainties affecting the Company, see the Company’s filings with the Securities and Exchange Commission, including its Annual Report on Form 20-F filed on February 25, 2026. Forward-looking statements speak only as of the date of this presentation, and the Company disclaims any obligation to update them except as required by applicable law.PD01B is an investigational product candidate and has not been approved by the FDA or any other regulatory authority. Views expressed by Dr. Warren Joseph are his own.
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Today’s Agenda 3 1. PolyPid Today – What We’ve Delivered2. PolyPid 20303. Introducing PD01B for Diabetic Foot Infections4. KOL presentation: Warren Joseph, DPM, FIDSA5. Timelines6. Q&A YL1
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Slide 3 YL1 Arx: Changed "Diabetic Foot Ulcers" to "Diabetic Foot Infections" (per Jonny's DFI decision in the script) and "D.P.M" to "DPM". ARX-YL, 2026-10-15T12:00:00
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Last Six Months: Promised and DeliveredSigned commercial, supply, and development deal with Azurity Pharma•>$320M in development and sales milestones. $30M already paid•Tiered royalties on net sales ranging from mid-teen to mid-twenties percentages•Pre-negotiated transfer price per vial•Azurity to fund clinical development for label expansion4 NTAP submitted. CMS decision expected August 2027 D-PLEX100dossier submitted for EMA review and validated NDA under FDA Priority Review•Target PDUFA date: November 28, 2026•Expected launch – early 2027 Regained full European commercial rights to D-PLEX100
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PolyPid 2030 5 3 major growth levers for PolyPid with near-, mid- and long-term value driversMaximize Azurity PartnershipExpand label beyond colorectal surgerywith clinical work funded by AzurityExpand D-PLEX100geographicallyUS and Canada signed. Expand to Europe and other territories through partnershipsBuild a Kynatrix -based pipelineIn-house and external development leveraging PolyPid’s long-acting, controlled-release technologyNEAR TERM NEAR AND MID TERM MID TO LONG TERM
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6 Lever 1: Label Expansion Beyond Colorectal Surgery1stExpansion to Abdominal surgery including GI tract, hysterectomies, etc.•Initiate FDA conversation Q4 2026•4 million surgeries, close to half are open procedures1Possible follow-on surgeries:Bone-tissue surgery•Trauma, bone fractures, fixations 800K – 1 million1/ year•Lumbar fusion – ~275K / year3 Soft-tissue surgery•Breast reconstruction - ~160K / year2•Post-weight-loss body contouring (Panniculectomies) – fast growing segment2 SSI isn’t a colorectal problem only; it’s a surgery problem 1. IQVIA PM&I Global FlexView. Internal analysis ; 2. https://www.plasticsurgery.org/documents/news/statistics/2025/plastic-surgery-statistics-report-2025.pdf; 3. lumbar fusion volume derived from AHRQ HCUP National Inpatient Sample and Nationwide Ambulatory Surgery Sample
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Lever 2: Open New Markets for D-PLEX100 7 U.S. & CANADAUS: launch expected in early 2027 subject to approvalCanada: NDS submission 2027 EUROPERights regained, MAA submitted; Currently reviewed under the centralized procedure.In active discussions with potential partners OTHER POTENTIAL TERRITORIESUnder assessment
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Lever 3: Kynatrix Innovation Strategy 8 Surgical Site InfectionMetabolic Diseases& ObesityInfection Treatment Leverage the power of the Kynatrix delivery technology to elevate treatment effectiveness Key Therapeutic Areas Develop in-house and Collaborate with R&D partners to: Improve efficacy Extend release of molecules Minimize systemic side effects and toxicity
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Kynatrix Pipeline – 2030 ViewOne platform, prevention and treatmentPreclinical IND-enabling Phase 2 Phase 3 Regulatory reviewMarketD-PLEX₁₀₀SSI prevention, colorectal surgeryPDUFA Nov 28, 2026 (U.S.); MAA under review (EU); NDS (Canada) submission 2027D-PLEX₁₀₀Label expansion, additional surgeriesAbdominal surgeries and other indications under evaluationPD01BTreatment of diabetic foot infectionPre-IND 2H 2027; First-in-Human 2H 2027PD03ALong-acting GLP-1 (metabolic)Early pre-clinical work on-goingStage bars are illustrative. PD01B and PD03A are investigational.9
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40.1 M1Diabetic Foot Infection: A Large, Underserved Need 19–34%2lifetime risk of a diabetic foot ulcer for people with diabetes #12diabetic foot infection is the most frequent diabetes complication requiring hospitalization, and the most common precursor of amputation ~1 in 52moderate or severe diabetic foot infections end in some level of amputation $52K3Cost of care for patients undergoing lower extremity amputation. Patients are seen by their outpatient health care provider about 12 times per year and are hospitalized about 2 times per year.Why it’s hard: an infected ulcer is a local problem. Poor blood flow limits how much systemic antibiotic reaches the wound. Getting enough antibiotics, for long duration, into infected tissue is the gap.1. CDC National Diabetes Statistics Report Sept. 2026; 2. IWGDF/IDSA Guidelines on the Diagnosis and Treatment of Diabetes-related Foot Infections, 2023 (Senneville et al., Clin Infect Dis); 3. Margolis DJ, Malay DS, Hoffstad OJ, et al. Economic burden of diabetic foot ulcers and amputations. 2011 Mar 8. In: Data Points Publication Series [Internet]. Rockville (MD): Agency for Healthcare Research and Quality (US); 2011-. Data Points #3. people with diagnosed or undiagnosed diabetes in the U.S.
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11 What is it?Hyper-local doxycycline released in the wound for several weeks PD01B – Kynatrix for Treatment of Diabetic Foot Infections Indication for useTreatment of moderate to severe diabetic foot infection (DFI) after wound debridement Development pathwayNew NDA under the 505(b)(2) pathway, separate from D-PLEX100
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Same Technology. A New Product.PD01BD-PLEX₁₀₀Treat established infectionPrevent infectionGoal Treatment of moderate to severe diabetic foot infectionsPrevention of SSI after colorectal surgeryIndicationPodiatrists & wound-care specialists; wound clinicSurgeons; operating roomPhysician / settingSeveral weeks; hyper local concentration30 daysRelease profile505(b)(2); New NDA505(b)(2); NDA No. 220740; PDUFA Nov. 28, 2026Regulatory pathPolyPid, worldwideAzurity (U.S. & Canada); PolyPid elsewhereCommercial rightsNew patent application recently submittedPrevention of SSI – September 2035Intellectual Property Shared: active ingredient (doxycycline), Kynatrix technology, manufacturing site and processes, preclinical and safety foundation.
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Why PD01B Can Move Faster 13 PD01B doesn’t start from zero: experience gained with D-PLEX100may help streamline its developmentWHAT WE ALREADY HAVE✓Known active ingredientDoxycycline a broad-spectrum antibiotic, with a long, well-characterized safety record✓Validated platformKynatrix , proven in Phase 3 (SHIELD II)✓Formulation designProduct based on D-PLEX₁₀₀✓CMC at an advanced stageSame manufacturing site and similar processes✓Preclinical & safety foundationTox package leveraged; > 1000 patients treated with D-PLEX₁₀₀ EXPECTED MILESTONES2H 2027Pre-IND meeting2H 2027First-in-human
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KOL Presentation:Dr. Warren Joseph 14
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Warren S. Joseph, DPM, FIDSAAdjunct Clinical ProfessorArizona College of Podiatric MedicineEditor-in-Chief, Journal of the American Podiatric Medical Association
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Topics to CoverWhat is the scope of the problem?What happens when it goes wrong?What are the advantages of topical antibiotics?What topicals have been tried and failed?Where does PD01B fit in?
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Scope of the problemThe International Diabetes Federation (IDF) estimates 589 million people in the world have diabetes and 38.5 million in the USOver 4 in 10 with diabetes are unaware they have itBy 2050 cases are expected to reach 853 million~1 in 3 will develop a foot ulceration in their lifetimeIn North America active ulcer rates are estimated to be 13% (one of the highest in the world)https://idf.org/
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Infection in Diabetic Foot Ulcers50-60% of all diabetic foot ulcers (DFUs) will become infectedThe single most common reason for hospitalization in people with diabetesUp to 20% will develop osteomyelitisPatients with diabetes are 25x more likely to undergo amputation85% of all amputations are preceded by a foot ulcerEvery 20 seconds, somewhere in the world, a limb is amputatedEdmonds M, The current burden of diabetic foot disease. J Clin Orthop Trauma. 2021 Feb 8;17:88-93. doi: 10.1016/j.jcot.2021.01.017
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Mortality Rates vs. Common Cancers5-year mortality (%)Source: Armstrong DG, Wrobel J, Robbins JM. Guest Editorial: are diabetes-related wounds and amputations worse than cancer? Int Wound J. 2007 Dec;4(4):286-7. doi: 10.1111/j.1742-481X.2007.00392.x
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Clinical Infectious Diseases, 2012:54 (15 June) Cited 2905 times as of Feb 2026
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Senneville E, et al. Clinical Infectious Diseases, 2023IWGDFGUIDELINES.ORG
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IDSA/IWGDF Severity Scale 2023 IDSA: Infectious Diseases Society of America; IWGDF: International Working Group on the Diabetic Foot
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Non-infected “Clean Ulcer”
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Mild Infections
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Moderate Infection
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Severe Infection
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What do the Guidelines say about topical antibiotics?
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Recommendation 24 We suggest not using topical (sponge, cream, and cement) antibiotics in combination with systemic antibiotics for treating either soft-tissue infections or osteomyelitis of the foot in patients with diabetes. (Conditional; Low)
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There is also insufficient evidence on whether adjunctive agents meaningfully affect clinical outcome and the safety of routinely using local antibiotics has not yet been clearly established. Therefore, we elected to suggest against the use of topical antibiotics. Future studies should apply learnings from prior studies to ensure statistically robust and clinically useful randomized controlled trials (RCTs). (Listed as an area of high interest)
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Advantages of TopicalsAchieve high local concentrationsLimited systemic absorptionReduce overall antibiotic exposureSTEWARDSHIP!Reduce adverse eventsReduce development of resistanceFew disadvantagesSoldevila-Boixader, et.al. Local Antibiotics in the Treatment of Diabetic Foot Infections: A Narrative Review. Antibiotics 2023, 12, 124.
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Topical Rationale/QuestionsAll wounds are colonized – many with methicillin-resistant Staphylococcus aureus (MRSA)Could reduction in colonization decrease subsequent infection rate?Could reduction in colonization increase healing rate?The only way to prevent infection in a wound and complications such as amputation…is to heal it!
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What has been tried?
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Results of 2 placebo-controlled trials of a new topical antibiotic for treating mild diabetic foot infection (DFI)• Trial of topical antibiotic treatment in mild DFI is feasible; can be safely conducted• Trial including a “placebo” group in mild DFI is feasible; can be safely conducted• Important information gained regarding natural history of mild DFI• Topical treatment with pexiganan cream did not show statistically significant superiority over vehicle in clinical or microbiological outcomes under the conditions of these trials• Standardized (and unusually intensive) wound care alone in this population was sufficient to eliminate infection in ~50% of cases.• An unexpectedly high rate of local infection-related complications was seen in the pexiganan groups.
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What does all the evidence show?
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Where does PD01B fit in?Doxycycline is a good antibiotic candidate for this situationIt is active against the most common bacteria found in diabetic foot infections (DFIs): Staphylococcus (including MRSA) and StreptococcusHas inherent anti-inflammatory activityClinical data supports claims that it helps heal wounds and decrease scarring Well-characterized with an established clinical safety profileElevated and prolonged local antibiotic levels with little systemic exposure Ideal from an antibiotic stewardship perspectiveMay support less frequent dressing changes
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Expected Levers for Growth 44 2026 202720282029Lever 1:Maximize with AzurityPDUFANov 28, 2026U.S. launch2027NTAP decisionAug 2027Label expansionLever 2:Geographic expansionMAA submittedSept 2026EMA decision2H 2027Lever 3:Kynatrix pipelinePD01B pre-IND meeting2H2027PD01B First-in-Human2H 2027 Canada submission2027EU launch2028 DH1
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Slide 44 DH1 Pls adjust as mentioned above Dalit Hazan, 2026-10-12T08:47:46.692
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