View Future GrowthPolyPid 과거 순이익 실적과거 기준 점검 0/6PolyPid의 연간 평균 수익은 8.7%였으며, Pharmaceuticals 산업의 수익은 연간 9.4% 증가했습니다.핵심 정보8.72%순이익 성장률55.11%주당순이익(EPS) 성장률Pharmaceuticals 산업 성장률5.95%매출 성장률n/a자기자본이익률-383.02%순이익률n/a최근 순이익 업데이트31 Mar 2026최근 과거 실적 업데이트공시 • May 06PolyPid Ltd. to Report Q1, 2026 Results on May 13, 2026PolyPid Ltd. announced that they will report Q1, 2026 results Pre-Market on May 13, 2026공시 • Jan 28PolyPid Ltd. to Report Q4, 2025 Results on Feb 11, 2026PolyPid Ltd. announced that they will report Q4, 2025 results Pre-Market on Feb 11, 2026공시 • Oct 29PolyPid Ltd. to Report Q3, 2025 Results on Nov 12, 2025PolyPid Ltd. announced that they will report Q3, 2025 results at 9:30 AM, US Eastern Standard Time on Nov 12, 2025공시 • Jul 30PolyPid Ltd. to Report Q2, 2025 Results on Aug 13, 2025PolyPid Ltd. announced that they will report Q2, 2025 results Pre-Market on Aug 13, 2025공시 • Apr 29PolyPid Ltd. to Report Q1, 2025 Results on May 14, 2025PolyPid Ltd. announced that they will report Q1, 2025 results at 9:30 AM, US Eastern Standard Time on May 14, 2025공시 • Jan 29PolyPid Ltd. to Report Q4, 2024 Results on Feb 12, 2025PolyPid Ltd. announced that they will report Q4, 2024 results Pre-Market on Feb 12, 2025모든 업데이트 보기Recent updates공시 • May 06PolyPid Ltd. to Report Q1, 2026 Results on May 13, 2026PolyPid Ltd. announced that they will report Q1, 2026 results Pre-Market on May 13, 2026공시 • Apr 29PolyPid Ltd Presents Data From SHIELD II Phase 3 Trial Demonstrating Reduced Severity Of Surgical Site InfectionPolyPid Ltd. announced that it will present at the 45th Annual Meeting of the Surgical Infection Society, taking place on May 5-6, 2026, at the Coronado Island Marriott in Coronado, California. The presentation will focus on a detailed analysis of the ASEPSIS (Additional treatment, Serous discharge, Erythema, Purulent exudate, Separation of deep tissues, Isolation of bacteria, and prolonged Stay as inpatient) score data from the Company's Phase 3 SHIELD II trial of D-PLEX100. The ASEPSIS score is a validated, objective clinical scoring system used to assess the severity of surgical wound infections. It integrates parameters such as wound appearance, antibiotic use, drainage of pus, isolation of pathogenic bacteria, and length of hospital stay. As previously reported in the SHIELD II topline results, treatment with D-PLEX100 together with the standard of care resulted in a 64% relative risk reduction (p=0.0103) in the proportion of patients with an ASEPSIS score greater than 20, the threshold indicative of clinically significant wound infection, compared to the standard of care alone. Surgical Infection Society 2026 Annual Meeting Presentation Details: Title: Evaluation of ASEPSIS Score as a Secondary Endpoint in the Phase 3 SHIELD II Trial of D-PLEX100 in Colorectal Surgery; Session: Scientific Session III; Date/Time: Wednesday, May 6, 2026 | 8:00 a.m. – 9:00 a.m. PT; Location: Coronado Island Marriott, Coronado, California. D-PLEX100, PolyPid’s lead product candidate, is designed to provide local prolonged and controlled anti-bacterial activity directly at the surgical site to prevent surgical site infections (“SSIs”). Following the administration of D-PLEX100 into the surgical site, PolyPid’s delivery technology, Kynatrix, pairs with Active Pharmaceutical Ingredients, enabling a prolonged and continuous release of the broad-spectrum antibiotic doxycycline, resulting in a high local concentration of the drug for a period of 30 days for the prevention of SSIs, with additional potential to prevent SSIs caused by antibiotic-resistant bacteria at the surgical site. D-PLEX100 recently demonstrated positive results in the Phase 3 SHIELD II trial, achieving a statistically significant 60% (p=0.0013) relative risk reduction in SSI incidence following abdominal colorectal surgery with large incisions. D-PLEX100 received Breakthrough Therapy designation from the U.S. Food and Drug Administration for the prevention of SSIs in patients undergoing elective colorectal surgery.공시 • Apr 14PolyPid Ltd Announces New Phase 3 Shield II Data Demonstrating D-Plex100 Sustained Local ReleasePolyPid Ltd. announced that the Company will present new pharmacokinetic data from the Phase 3 SHIELD II trial evaluating D-PLEX100 at the Congress of the European Society of Clinical Microbiology and Infectious Diseases Global 2026, taking place on April 17-21, 2026, in Munich, Germany. The abstract titled “Pharmacokinetics of local extended-release incisional doxycycline in patients undergoing abdominal colorectal surgery from the SHIELD II Phase 3 clinical trial,” was co-authored by Prof. Antonino Spinelli, Director of the Division of Colon and Rectal Surgery and a Professor of Surgery at Humanitas University, in Milan, Italy and PolyPid. Sustained and controlled release profile: Detectable doxycycline concentrations were observed for up to 763 hours (approximately 32 days), with no burst, following local application of D-PLEX100 during surgery. Minimal systemic exposure: Plasma doxycycline concentrations remained below 100 ng/mL, indicating negligible systemic levels relative to oral doxycycline administration where Cmax levels are approximately 16 to 26 times higher (1,613.3 ng/mL for 100 mg and 2,600 ng/mL for 200 mg doses). ESCMID Global 2026 Presentation Details Poster Title: Pharmacokinetics of Local Extended-Release Incisional Doxycycline in Patients undergoing Abdominal Colorectal Surgery from the SHIELD II Phase 3 Clinical Trial Presenter: Eyal Shoshani, VP Clinical Affairs, PolyPid Ltd. Lead Author: Prof. Antonino Spinelli, Humanitas University and IRCCS Humanitas Research Hospital, Milan, Italy Poster Details: #P2740 (Presented at: Poster Hall B3) Session: 05b. Pharmacokinetics/pharmacodynamics of antibacterial drugs & therapeutic drug monitoring Date/Time: Sunday, April 19, 2026 | 12:00 – 13:30 CEST The abstract will be available once the conference concludes. D-PLEX100, PolyPid’s lead product candidate, is designed to provide local prolonged and controlled anti-bacterial activity directly at the surgical site to prevent surgical site infections (“SSIs”). Following the administration of D-PLEX100 into the surgical site, PolyPid’s delivery technology, Kynatrix, pairs with Active Pharmaceutical Ingredients, enabling a prolonged and continuous release of the broad-spectrum antibiotic doxycycline, resulting in a high local concentration of the drug for a period of 30 days for the prevention of SSIs, with additional potential to prevent SSIs caused by antibiotic-resistant bacteria at the surgical site. D-PLEX100 recently demonstrated positive results in the Phase 3 SHIELD II trial, achieving a statistically significant 60% (p=0.0013) relative risk reduction in SSI incidence following abdominal colorectal surgery with large incisions. D-PLEX100 received Breakthrough Therapy designation from the U.S. Food and Drug Administration for the prevention of SSIs in patients undergoing elective colorectal surgery.새로운 내러티브 • Apr 04Long Regulatory And Commercial Risks Around Lead Therapy Could Eventually Reward Patient HoldersCatalysts About PolyPid PolyPid is a biopharmaceutical company developing locally and systemically delivered, long acting therapies based on its proprietary drug delivery technology, with D PLEX100 for prevention of surgical site infections as its lead program. What are the underlying business or industry changes driving this perspective?공시 • Mar 31Polypid Ltd Initiates D-Plex100 Nda Submission to FdaPolyPid Ltd. had initiated a New Drug Application submission to the U.S. Food and Drug Administration for D-PLEX100 for the prevention of surgical site infections in patients undergoing colorectal surgery. The NDA is being submitted under the FDA’s Fast Track designation, which allows for rolling review. The submission includes the Chemistry, Manufacturing and Controls and nonclinical sections of the NDA, with additional components, including the clinical section, expected to be submitted in the Second Quarter of 2026. D-PLEX100, PolyPid’s lead product candidate, is designed to provide local prolonged and controlled anti-bacterial activity directly at the surgical site to prevent surgical site infections. Following the administration of D-PLEX100 into the surgical site, PolyPid’s delivery technology, Kynatrix, pairs with Active Pharmaceutical Ingredients, enabling a prolonged and continuous release of the broad-spectrum antibiotic doxycycline, resulting in a high local concentration of the drug for a period of 30 days for the prevention of surgical site infections, with additional potential to prevent surgical site infections caused by antibiotic-resistant bacteria at the surgical site. D-PLEX100 recently demonstrated positive results in the Phase 3 SHIELD II trial, achieving a statistically significant 60% (p=0.0013) relative risk reduction in surgical site infection incidence following abdominal colorectal surgery with large incisions. D-PLEX100 received Breakthrough Therapy Designation from the FDA for the prevention of surgical site infections in patients undergoing elective colorectal surgery.새로운 내러티브 • Mar 19Regulatory Tailwinds And Extended Release Platform Will Shape A Stronger Long Term OutlookCatalysts About PolyPid PolyPid is a biopharmaceutical company focused on extended release drug delivery products such as D-PLEX100 for prevention of surgical site infections and longer acting metabolic therapies using its Kynatrix technology. What are the underlying business or industry changes driving this perspective?공시 • Mar 17PolyPid Ltd Announces PDUFA Fee Waiver And NDA Submission Plans For D-PLEX100PolyPid Ltd. announced that the U.S. Food and Drug Administration (FDA) has granted a small business waiver of the Prescription Drug User Fee Act (PDUFA) fee of approximately USD 4.3 million for the New Drug Application (NDA) for D-PLEX100, the Company's lead product candidate for the prevention of surgical site infections (SSIs) in abdominal colorectal surgeries. This meaningful waiver advances PolyPid toward its upcoming NDA submission initiation and enables the Company to focus its resources on commercialization preparations, following the successful Phase 3 SHIELD II trial which demonstrated a 60% (p=0.0013) relative risk reduction in surgical site infections and met its primary and all key secondary endpoints. The Company remains on track to submit the first sections of its rolling NDA by the end of this month, following positive feedback from the FDA during the pre-NDA meeting communication completed in December 2025.새로운 내러티브 • Mar 05Long Acting Drug Delivery And Metabolic Health Pipeline Will Transform Future ProspectsCatalysts About PolyPid PolyPid is a clinical stage biopharmaceutical company focused on long acting drug delivery products such as D PLEX100 for prevention of surgical site infections and a GLP 1 receptor agonist program for metabolic disease. What are the underlying business or industry changes driving this perspective?공시 • Jan 28PolyPid Ltd. to Report Q4, 2025 Results on Feb 11, 2026PolyPid Ltd. announced that they will report Q4, 2025 results Pre-Market on Feb 11, 2026Breakeven Date Change • Dec 31Forecast to breakeven in 2028The 4 analysts covering PolyPid expect the company to break even for the first time. New consensus forecast suggests the company will make a profit of US$5.60m in 2028. Average annual earnings growth of 54% is required to achieve expected profit on schedule.공시 • Dec 17PolyPid Ltd. Appoints Brooke Story as Chairman of the Board of Directors, Effective December 11, 2025PolyPid Ltd. announced the appointment of Brooke Story as Chairman of the Board of Directors, effective as of December 11, 2025. Ms. Story brings over 25 years of leadership experience in the MedTech industry, having held senior roles at BD (Becton, Dickinson and Company) and Medtronic PLC. As former Worldwide President of BD’s Surgery business, she oversaw global strategy and the P&L for portfolios in hernia repair, tissue repair, and infection prevention. In addition, she has extensive experience leading mergers and acquisitions as well as licensing transactions. She currently serves as BD’s Separation and Integration Lead, managing the Life Sciences divestiture and ongoing global integrations. Alongside her new role with PolyPid, Ms. Story currently serves as a non-executive director on the Board of LivaNova PLC. She previously served on the Board of Sigilon Therapeutics Inc. and as Board observer for Avation Medical Inc. She holds a Bachelor of Science in Engineering from the University of Tennessee and an MBA from the University of Michigan.공시 • Dec 03PolyPid Ltd. Announces Positive Fda Pre-Nda Meeting Minutes for D-Plex100 Supporting Nda SubmissionPolyPid Ltd. announced that it has received a formal pre-New Drug Application ("NDA") meeting minutes from the U.S. Food and Drug Administration ("FDA") supporting the NDA submission of D-PLEX100, the Company's lead product candidate for the prevention of surgical site infections in abdominal colorectal surgeries. The FDA agreed that the Company's existing clinical data package, including results from the Phase 3 SHIELD II trial, appears adequate to support NDA submission and review. The FDA also agreed to a rolling NDA review, allowing PolyPid to submit the first completed sections in early 2026. Based on the FDA's Pre-NDA meeting written response, the Company concludes that the objectives of the pre-NDA meeting have been accomplished and has determined that the in-person meeting, originally scheduled for December 3, 2025, is no longer necessary. About D-PLEX100: D-PLEX100, PolyPid's lead product candidate, is designed to provide local prolonged and controlled anti-bacterial activity directly at the surgical site to prevent surgical site infections ("SSIs"). Following the administration of D-PLEX100 into the surgical site, the PLEX (Polymer-Lipid Encapsulation matriX) technology pairs with Active Pharmaceutical Ingredients, enabling a prolonged and continuous release of the broad-spectrum antibiotic doxycycline, resulting in a high local concentration of the drug for a period of 30 days for the prevention of SSIs, with additional potential to prevent SSIs caused by antibiotic-resistant bacteria at the surgical site. D-PLEX100 recently demonstrated positive results in the Phase 3 SHield II trial, achieving a statistically significant 58% (p< 0.005) relative risk reduction in SSI incidence following abdominal colorectal surgery with large incisions. D-PLEX100 received Breakthrough Therapy designation from the U.S. food and Drug Administration for the prevention of SSIs in patients undergoing elective colorectal surgery.New Risk • Nov 14New major risk - Financial positionThe company has less than a year of cash runway based on its current free cash flow trend. Free cash flow: -US$26m This is considered a major risk. With less than a year's worth of cash, the company will need to raise capital or take on debt unless its cash flows improve. This would dilute existing shareholders or increase balance sheet risk. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$26m free cash flow). Shareholders have been substantially diluted in the past year (130% increase in shares outstanding). Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$2.5m net loss in 3 years). Market cap is less than US$100m (US$58.7m market cap).공시 • Oct 29PolyPid Ltd. to Report Q3, 2025 Results on Nov 12, 2025PolyPid Ltd. announced that they will report Q3, 2025 results at 9:30 AM, US Eastern Standard Time on Nov 12, 2025분석 기사 • Oct 28Is PolyPid (NASDAQ:PYPD) A Risky Investment?The external fund manager backed by Berkshire Hathaway's Charlie Munger, Li Lu, makes no bones about it when he says...공시 • Oct 01Polypid Ltd. to Present Its Positive Phase 3 Shield II Topline Results At the 2025 American College of Surgeons Clinical CongressPolyPid Ltd. announced that Dr. Shmuel Sharoni will present the topline results from the Company's successful Phase 3 SHIELD II trial of D-PLEX100 at the upcoming 2025 American College of Surgeons (ACS) Clinical Congress in Chicago, IL. The SHIELD II Phase 3 trial was a prospective, multinational, randomized, double-blind study that successfully met its primary and all key secondary efficacy endpoints. The trial demonstrated that D-PLEX100, when administered alongside standard of care, achieved a 38% reduction (p<0.005) in the combined endpoint of surgical site infections, reinterventions, or mortality compared to standard of care alone. Additionally, the trial showed a 58% reduction (p<0.005) in the rate of surgical site infections in the D-PLEX100 treatment arm.공시 • Sep 16PolyPid Successfully Completes Israeli Ministry of Health GMP InspectionPolyPid Ltd. announced the successful completion of a routine Good Manufacturing Practice (GMP) inspection by the Israeli Ministry of Health. The inspection, concluded earlier this week, marks the fourth consecutive successful GMP inspection of PolyPid's manufacturing facility. The Israeli Ministry of Health operates under the EU-Israel Agreement on Conformity Assessment and Acceptance (ACAA) framework, whereby European regulatory authorities rely on these inspections for EU GMP compliance certification. This regulatory equivalence confirms that PolyPid's manufacturing facility meets the standards required for commercial production in the European market. The inspection comprehensively evaluated PolyPid's quality systems, manufacturing processes, and facility operations, confirming the Company's readiness to support commercial production of D-PLEX100 following regulatory approvals.공시 • Aug 12PolyPid Ltd. Announces Management ChangesPolyPid Ltd. announced the appointment of Dr. Nurit Tweezer-Zaks, M.D., M.B.A., as Chief Medical Officer, effective as of August 18, 2025. Dr. Tweezer-Zaks, who has served on PolyPid's Board of Directors (the “Board”) since November 2023, will step down from the Board, effective as of August 17, 2025 as she assumes this new executive role. Dr. Tweezer-Zaks brings to PolyPid extensive executive, medical, and research and development expertise. Prior to joining PolyPid, she served as Chief Executive Officer of MediCane Health Inc., a fully integrated global medical cannabis company. Previously, Dr. Tweezer-Zaks held senior positions at aMOON Venture Capital Fund, a leading Israel-based life sciences-focused venture capital investor, where she most recently served as Chief Medical Officer. She also held increasingly senior positions at Sanofi, where she focused on external innovation and partnering and on life cycle management of portfolio products as Global Established Products Medical Lead. Dr. Tweezer-Zaks began her career as a practicing internal medicine and rheumatology physician at Sheba Medical Center in Israel for nearly 15 years. Dr. Tweezer-Zaks holds M.D. and B.S. degrees from Ben-Gurion University School of Medicine in Beer Sheva, Israel, and earned an M.B.A. from the Kellogg-Recanati International Executive MBA Program, a global partnership program between Northwestern University'sKellogg School of Management in Evanston, IL, and Tel Aviv University'sRecanati Graduate School of Business Administration in Israel.공시 • Jul 30PolyPid Ltd. to Report Q2, 2025 Results on Aug 13, 2025PolyPid Ltd. announced that they will report Q2, 2025 results Pre-Market on Aug 13, 2025공시 • Jul 15PolyPid Ltd. Unveils A Long-Acting GLP-1 Receptor Agonists Delivery Platform Targeting the Diabetes and Weight Loss MarketPolyPid Ltd. unveiled its long-acting GLP-1 receptor agonists (glucagon-like peptide-1 RA) delivery platform which aims to subcutaneously release GLP-1 RA for approximately 60 days, significantly longer than current weekly injection regimens. The platform releases GLP-1 in a linear way, overcoming the burst release seen with the current weekly delivered molecules. This discovery has the potential to significantly expand PolyPid's offering to a market which is projected to reach $100 billion by 2030. PolyPid's proprietary technology is a sophisticated drug delivery system consisting of a polymer-lipid based matrix that creates a protected drug reservoir. This unique matrix architecture enables controlled and continuous drug delivery in the body over a prolonged time (we weeks to months) in a single application. The technology has been clinically validated in over 1,000 patients including in two Phase 3 trials with no major safety concern.공시 • Jun 10PolyPid Announces Positive Topline Results from Phase 3 SHIELD II Trial: D-PLEX100 Demonstrated Significant Reduction in Surgical Site Infections and Successfully Met Primary and All Key Secondary EndpointsPolyPid Ltd. announced positive topline results from its pivotal SHIELD II Phase 3 trial of D-PLEX100 for the prevention of SSIs in patients undergoing abdominal colorectal surgery with large incisions, which has received Fast Track designation from the FDA. Key findings from SHIELD II study include: The primary efficacy endpoint of the study was successfully met, with a significantly lower proportion of primary endpoint events among patients who received D-PLEX100 plus SoC (n=405; 10. 9%), compared to SoC alone (n=393; 18. 1%), representing a 38% reduction (p<0. 005). The primary endpoint is the combination of deep and superficial SSIs, all-cause mortality and surgical reinterventions at the same incision of the original index surgery. SHIELD II included three key secondary endpoints: The first key secondary endpoint was met, with a 58% reduction in deep and superficial SSI rates among patients who received D-PLEX100 plus SoC (3. 8%) compared to those who received SoC alone (9.5%) (p<0. 005). The second key secondary endpoint showed statistical significance in favor of D-PLEX100 plus SoC over SoC alone (p<0. 005). This efficacy endpoint combined SSI, mortality and reintervention as evaluated in the primary endpoint. This endpoint was assessed in the overall study population of 975 patients with an incision =7 cm, including laparoscopic surgery patients enrolled prior to the 2023 trial protocol change. The third key secondary endpoint was met with a 62% reduction of patients with an ASEPSIS score >20 in D-PLEX100 plus SoC arm compared to SoC alone arm (p<0. 05). The ASEPSIS score is a clinical tool used to objectively assess surgical wound infections. There were no safety concerns raised by the independent Data Safety Monitoring Board in SHIELD II.Breakeven Date Change • Jun 06No longer forecast to breakevenThe 4 analysts covering PolyPid no longer expect the company to break even during the foreseeable future. The company was expected to make a profit of US$55.6m in 2027. New consensus forecast suggests the company will make a loss of US$20.1m in 2027.공시 • May 23PolyPid Ltd., Annual General Meeting, Jun 25, 2025PolyPid Ltd., Annual General Meeting, Jun 25, 2025. Location: 18 hasivim street, petach tikva 4959376, Israel공시 • Apr 29PolyPid Ltd. to Report Q1, 2025 Results on May 14, 2025PolyPid Ltd. announced that they will report Q1, 2025 results at 9:30 AM, US Eastern Standard Time on May 14, 2025공시 • Mar 11PolyPid Ltd. Announces Successful Completion of Enrollment in Phase 3 SHield II Trial of D-PLEX100 for the Prevention of Abdominal Colorectal Surgical Site InfectionsPolyPid Ltd. announced the successful completion of enrollment in the SHIELD II Phase 3 trial for D-PLEX100 for the prevention of surgical site infections in patients undergoing abdominal colorectal surgery. This milestone follows recommendation by the independent Data Safety Monitoring Board ("DSMB"), which, after analyzing unblinded efficacy data from the first 430 enrolled patients in the trial, recommended concluding the study upon enrollment of 800 patients, the lowest sample size reassessment stop after the minimum planned number of patients. The Company anticipates reporting top-line results by the end of the second quarter of 2025. If the Phase 3 data are positive, PolyPid expects to submit a New Drug Application ("NDA") to the U.S. Food and Drug Administration ("FDA"), leveraging the FDA's Fast Track and Breakthrough Therapy designations.공시 • Jan 29PolyPid Ltd. to Report Q4, 2024 Results on Feb 12, 2025PolyPid Ltd. announced that they will report Q4, 2024 results Pre-Market on Feb 12, 2025공시 • Dec 24PolyPid Ltd. Announces Positive Recommendation by DSMB to Continue Enrollment of Phase 3 SHield II Trial of D-PLEX100 to 800 Patients with a Concurrent Private Placement of Up to $41 MillionPolyPid Ltd. announced that following the independent Data Safety Monitoring Board's review of unblinded efficacy data from the first 430 enrolled patients in the SHIELD II Phase 3 trial for D-PLEX100 for the prevention of surgical site infections in patients undergoing abdominal colorectal surgery with large incisions, the DSMB's recommendation was to conclude the study upon enrollment of 800 patients, which is the lowest sample size reassessment stop after the minimum planned number of 624 patients. At this interim analysis, the DSMB also had the option to recommend stopping SHIELD II due to futility or overwhelming efficacy or to reassess the trial's sample size to a maximum of 1,100 patients. exercise of the warrants in full would result in an additional $27.0 million in gross proceeds to the Company. The PIPE is expected to close on December 26, 2024, subject to the satisfaction of customary closing conditions. The Company intends to use the net proceeds from the sale of the securities for its ongoing SHIELD II Phase 3 clinical trial, working capital and general corporate purposes. The gross proceeds from the financing extend PolyPid's cash runway into the third quarter of 2025, beyond expected top-line results from SHIELD II. Proceeds of all warrants issued in this transaction, if exercised, would provide the Company with capital beyond NDA approval. Citizens JMP is acting as exclusive placement agent in the offering.공시 • Nov 30PolyPid Announces Receipt of Nasdaq Notification of Minimum Stockholders’ Equity Non-CompliancePolyPid Ltd. announced that it has received a written notification (the "Notification Letter") from the Listing Qualifications staff of The Nasdaq Stock Market LLC (“Nasdaq”) notifying the Company that it is no longer in compliance with the minimum stockholders' equity requirement for continued listing on the Nasdaq Capital Market, listing Rule 5550(b)(1), due to its failure to maintain a minimum of $2,500,000 in stockholders' equity. In the Company's Form 6-K dated November 13, 2024, the Company reported stockholders' equity of approximately $2,158,000 as of September 30, 2024. In accordance with Nasdaq rules, the Company has 45 calendar days, or until January 9, 2025, to submit a plan to regain compliance. If the plan is accepted, Nasdaq can grant an extension of up to 180 calendar days from the date of the letter to evidence compliance. The Notification Letter has no immediate effect on the Company’s listing on the Nasdaq Capital Market, and during the grace period, as may be extended, the Company’s ordinary shares will continue to trade on Nasdaq under the symbol “PYPD”.Outcome of the unblinded interim analysis in Company’s ongoing SHIELD II Phase 3 trial evaluating D-PLEX100 for the prevention of abdominal colorectal surgical site infections is expected in December 2024. Under the terms of the Company’s private placement financing that closed in January 2024 (“January PIPE”), the Company has the potential to secure an additional $18.5 million if the unblinded interim analysis results in the stopping of the trial due to positive efficacy and all warrants are exercised. In addition, under the terms of the private placement financing that closed in August 2024 (“August PIPE”), the Company has the potential to secure an additional $6.1 million if the unblinded interim analysis results in either the stopping of the trial due to positive efficacy, or continuation to planned patient recruitment (up to 630 subjects) and all warrants are exercised. The Company expects that it will be able to demonstrate compliance with the Nasdaq stockholders’ equity requirement if warrants issued under the January PIPE and the August PIPE are exercised.공시 • Nov 10PolyPid Ltd. has filed a Follow-on Equity Offering in the amount of $8.25 million.PolyPid Ltd. has filed a Follow-on Equity Offering in the amount of $8.25 million. Security Name: Ordinary Shares Security Type: Common Stock Transaction Features: At the Market Offering공시 • Oct 30PolyPid Ltd. to Report Q3, 2024 Results on Nov 13, 2024PolyPid Ltd. announced that they will report Q3, 2024 results Pre-Market on Nov 13, 2024공시 • Jul 31PolyPid Ltd. to Report Q2, 2024 Results on Aug 14, 2024PolyPid Ltd. announced that they will report Q2, 2024 results Pre-Market on Aug 14, 2024공시 • Jun 18PolyPid Ltd. Hosts Kol Call to Discuss Significant Unmet Medical Need in Surgical Site Infections Prevention and Provides Update on Its Ongoing Shield II Phase 3 TrialPolyPid Ltd. hosted a virtual Key Opinion Leader event discussing the significant unmet medical need in the prevention of surgical site infections (SSIs). The Company also provided an update on its ongoing SHIELD II Phase 3 trial for D-PLEX100. Charles E. Edmiston, Ph.D. (Emeritus Professor of Surgery, Division of Vascular Surgery, Medical College of Wisconsin), discussed several key topics surrounding SSIs. Key takeaways include: The return to higher pre-COVID SSI rates due to the increase in the number of elective surgeries conducted and the surgical environment normalizing to levels found prior to 2020. SSIs are under-reported, and up to 30-35% of colorectal infections are missed due to sub-optimal surveillance strategies. Procedural and patient-related risk factors such as smoking, alcohol abuse, type 2 diabetes and a high BMI have a significant negative impact on the risk of developing a SSI, and this increase in risk is compounded when patients have multiple risk factors. Long term cost to commercial payers of a single colorectal SSI event over a period of 24 months can range from $44,000 (superficial SSI) to $64,000 (deep SSI), with the cost for Medicare ranging from $20,000 to $45,000, respectively. Surgical care bundles in patients undergoing colorectal surgery significantly reduce the risk of SSIs. The 30-day high concentration release of antibiotics achieved with D-PLEX100 has the potential to add additional benefit to infection prevention bundles. PolyPid also provided an update on the enrollment of its ongoing Phase 3 SHIELD II trial of its lead product candidate, D-PLEX100. The SHIELD II clinical study includes patients undergoing abdominal colorectal surgery with large incisions and has now enrolled approximately 250 patients of a planned total of approximately 600 subjects. Approximately 50 centers are currently open and recruiting patients. Top-line results are expected in the first quarter of 2025. The Company intends to conduct an unblinded interim analysis once a total of approximately 400 patients complete their 30-day follow-up, which is anticipated to occur in the fourth quarter of 2024.공시 • May 31PolyPid Ltd., Annual General Meeting, Jul 02, 2024PolyPid Ltd., Annual General Meeting, Jul 02, 2024. Location: 18 hasivim street, 4959376, petach tikva Israel공시 • Apr 30PolyPid Ltd. Announces Enrollment of 200th Patient in Ongoing SHIELD II Phase 3 Trial Evaluating D-PLEX100 for the Prevention of Abdominal Colorectal Surgical Site InfectionsPolyPid Ltd. announced that it has enrolled the 200th patient in its ongoing SHIELD II Phase 3 trial for D-PLEX100 for the prevention of surgical site infections in patients undergoing abdominal colorectal surgery with large incisions. The study is now approximately one-third enrolled and is anticipated to continue enrollment at a pace of 1.5 patients per center per month. There are currently approximately 40 centers open and the Company expects to add approximately 20 more centers over the next couple of months. An unblinded interim analysis is anticipated to be conducted in mid-2024, once a total of approximately 400 patients complete their 30-day follow-up.공시 • Apr 26PolyPid Ltd. to Report Q1, 2024 Results on May 08, 2024PolyPid Ltd. announced that they will report Q1, 2024 results Pre-Market on May 08, 2024공시 • Feb 12PolyPid Ltd. Announces Enrollment of the 100th Patient in the Ongoing Shield II Phase 3 TrialPolyPid Ltd. announced that it has enrolled and randomized the 100th patient in its ongoing SHIELD II Phase 3 trial for D-PLEX100 for the prevention of surgical site infections in patients undergoing abdominal colorectal surgery with large incisions. There are currently approximately 40 centers open. The Company intends to conduct an unblinded interim analysis once a total of approximately 400 patients complete their 30-day follow-up, which is expected to occur in mid-2024.공시 • Feb 01PolyPid Ltd. to Report Q4, 2023 Results on Feb 14, 2024PolyPid Ltd. announced that they will report Q4, 2023 results Pre-Market on Feb 14, 2024공시 • Jan 22PolyPid Ltd. announced that it has received $35.01012 million in funding from Dafna Capital Management, LLC, Rosalind Advisors, Inc.On January 22, 2024, PolyPid Ltd., closed the transaction. The company has raised $35,010,120 from 20 investors pursuant to Regulation D.공시 • Jan 05PolyPid Ltd. announced that it expects to receive $16.216011 million in funding from Dafna Capital Management, LLC, Rosalind Advisors, Inc. and other investorsPolyPid Ltd. announced that it has entered into a securities purchase agreement for a private placement financing to issue 3,371,312 of the Company’s ordinary shares at an issue price of $4.81 per share for the gross proceeds of $16,216,010.72 on January 4, 2023. The transaction will include participation from new and existing investors, including participation from new U.S. life sciences-focused investors, DAFNA Capital Management and Rosalind Advisors. The investors will also receive warrants to purchase up to 3,371,312 Ordinary Shares at an exercise price of $5.50 per share. The warrants expire upon the earlier of two years from the date of issuance Exercise of the warrants in full would result in an additional $18,500,0000 in gross proceeds to the Company.공시 • Nov 08Polypid Announces the Addition of Dr. Nurit Tweezer-Zaks to Its Board of DirectorsPolyPid Ltd. announced the appointment of Nurit Tweezer-Zaks, M.D., M.B.A, to its Board of Directors, effective November 6, 2023, following the retirement of Anat Tsour Segal. Dr. Tweezer-Zaks is a biopharmaceutical industry veteran with extensive executive business development, clinical, and R&D expertise. She is an experienced sector investor and was a practicing physician for nearly 15 years. Dr. Tweezer-Zaks currently serves as Chief Executive Officer of MediCane Health, a fully-integrated global medical cannabis company. Previously, Dr. Tweezer-Zaks served in increasingly senior positions at aMOON, a leading Israel-based life sciences-focused venture capital investor. In her most recent role as Chief Medical Officer at aMOON, she managed the internal and external interfaces across the fund between investors, portfolio companies, and investment teams, and provided professional input to the investment committee. Prior to this, Dr. Tweezer-Zaks held increasingly senior positions at Sanofi. In her most recent role at Sanofi, she served as Global Established Products Medical Lead – Strategic Decision for Portfolio Enhancement. In this role Dr. Tweezer-Zaks focused on life cycle management of portfolio products. She began her career as a practicing internal medicine physician at Sheba Medical Center in Israel. Dr. Tweezer-Zaks has authored numerous scientific publications. She holds M.D. and B.S. degrees from Ben-Gurion University School of Medicine in Beer Sheva, Israel, and earned an M.B.A. from the Kellogg-Recanati International Executive MBA Program, a global partnership program between Northwestern University’s Kellogg School of Management in Evanston, IL, and Tel Aviv University’s Recanati Graduate School of Business Administration in Israel.공시 • Nov 02PolyPid Ltd. to Report Q3, 2023 Results on Nov 08, 2023PolyPid Ltd. announced that they will report Q3, 2023 results Pre-Market on Nov 08, 2023공시 • Oct 12PolyPid Regains Compliance with Nasdaq Minimum Closing Bid Price RulePolyPid Ltd. announced that it has received a written notice from The Nasdaq Stock Market LLC ("Nasdaq") that the Company has regained compliance with the minimum bid price requirement for continued listing set forth in Nasdaq Listing Rule 5550(a)(2), which requires listed securities, including the Company's ordinary shares, to maintain a minimum bid price of $1.00 per share. The Nasdaq staff made this determination of compliance after the closing bid price of the Company's ordinary shares was at $1.00 per share or greater for the 11 consecutive business days prior to the date of the notice. Accordingly, the Company has regained compliance with Nasdaq Listing Rule 5550(a)(2), and Nasdaq considers the prior bid price deficiency matter now closed.공시 • Sep 21PolyPid Announces Reverse Share Split to Regain Compliance with Nasdaq’s $1.00 Minimum Bid Price RequirementPolyPid Ltd. (“PolyPid” or the “Company”) announced a reverse share split (the “Reverse Split”) of the Company’s issued and outstanding ordinary shares, no par value (“Ordinary Shares”), at the ratio of 1-for-30, such that each thirty Ordinary Shares, shall be consolidated into one Ordinary Share. The Company obtained shareholders’ approval for the Reverse Split at a ratio of between 1:10 and 1:30 at an extraordinary general meeting of shareholders, which took place on September 18, 2023. The Company’s board of directors then approved the Reverse Split ratio of 1-for-30 on September 18, 2023. The first date when the Company’s Ordinary Shares will begin trading on the Nasdaq Capital Market (“Nasdaq”) on a post- reverse split basis is expected to be September 21, 2023. The Company’s Ordinary Shares will continue to trade on the Nasdaq under the symbol “PYPD” and the Company expects that the reverse share split will allow the Company to regain compliance with Nasdaq’s $1.00 minimum bid price requirement.공시 • Sep 20PolyPid Ltd. Announces Successful Completion of Manufacturing Process Validation for D-PLEX100PolyPid Ltd. announced the successful completion of the production of three process validation batches of D-PLEX100 which have started stability program. This successful production process validation completes a substantial requirement toward the Company’s planned submission of D-PLEX100 New Drug Application (NDA) and Marketing Authorization Application (MAA) regulatory filings. PolyPid’s ongoing Phase 3 SHIELD II trial of D-PLEX100 for the prevention of surgical site infections (SSIs) is currently recruiting patients undergoing open abdominal colorectal surgery with large incisions. Top-line results are expected in mid-2024. D-PLEX100, PolyPid’s lead product candidate, is designed to provide local prolonged and controlled anti-bacterial activity directly at the surgical site to prevent SSIs. Following the administration of D-PLEX100 into the surgical site, the PLEX (Polymer-Lipid Encapsulation matriX) technology pairs with Active Pharmaceutical Ingredients, enabling a prolonged and continuous release of the broad-spectrum antibiotic doxycycline, resulting in a high local concentration of the drug for a period of 30 days for the prevention of SSIs, with additional potential to prevent SSIs caused by antibiotic-resistant bacteria at the surgical site. D-PLEX100 received Breakthrough Therapy Designation from the U.S. Food and Drug Administration for the prevention of SSIs in patients undergoing elective colorectal surgery. D-PLEX100 also received three Qualified Infectious Disease Product (QIDP) designations, and three Fast Track designations for the prevention of SSIs in patients undergoing elective colorectal surgery, post-abdominal surgery incisional infection and for the prevention of sternal wound infection post-cardiac surgery.공시 • Jul 28PolyPid Ltd. to Report Q2, 2023 Results on Aug 09, 2023PolyPid Ltd. announced that they will report Q2, 2023 results Pre-Market on Aug 09, 2023공시 • Jun 30Polypid Ltd. Announces New Publication Highlighting Potent Antibacterial Activity of D-Plex Against Susceptible and Resistant Bacteria for the Prevention of Surgical Site InfectionsPolyPid Ltd. announced a new publication highlighting the potent antibacterial activity of D-PLEX(100) and its potential as an effective prophylactic drug against the most prevalent bacteria causing surgical site infections (SSIs), including resistant strains. The paper, entitled, "Potent antibacterial activity in surgical wounds with local administration of D-PLEX(100) was recently published in the European Journal of Pharmaceutical Sciences and can be found here. The efficacy and safety of D-PLEX(50) for the prevention of abdominal colorectal SSIs are currently being further evaluated in the SHIELD II Phase 3 clinical trial. Top-line results are expected in mid-2024. Following the administration of D-PLEX (Polymer-Lipid Encapsulation matriX) technology pairs with Active Pharmaceutical Ingredients, enabling a prolonged and continuous release of the broad-spectrum antibiotic doxycycline, resulting in a high local concentration of the drug for a period of 30 days for the prevention of SSIs, with additional potential to prevent SSIs caused by antibiotic-resistant bacteria at the surgical site. D-PLEX(100") received Breakthrough Therapy Designation from the U.S. FDA for the prevention of SSIs in patients undergoing elective colorectal surgery. D-PLEX(100") also received three Qualified Infectious Disease Product (QIDP) designations, and three Fast Trackdesignations for the prevention of SSIsin patients undergoing elective coloreCTal surgery, post-abdominal surgery incisional infection and for the prevention of sternal wound infection post-cardiac surgery. Through locally administered, controlled,release therapeutics, PolyPid's proprietary PLEX (Polymer-LIPid Encapsulation matri X) technology pairs with Active Pharmaceutical ingredients (APIs), enabling precise delivery of drugs at optimal release rates over durations ranging from several days to months. PolyPid's lead product candidate D-PLEX(100). is in Phase 3 clinical trial for the prevention of abdominal colores colorectal SSIs are currently being further evaluated in the SHIELD II Phase 3 clinical trial. Top-line results are expected in mid-2024. About D-PLEX(100) D-PLEX(100,) PolyPid's lead product candidate, is designed to provide local prolonged and controlled anti-bacterial activity directly at the surgical site to prevent SSIs. Following the administration of D-PLEX(100) into the surgical site, the PLEX (Polymer-Lipid Encapsulation matriX) technology pairs with Active Pharmaceutical Ingredients, enabling a prolonged and continuous release of the broad-spectrum antibiotic doxycycline, resulting in a high local concentration of the drug for a period of 30 days for the prevention of SSIs, with additional potential to prevent SSIs caused by antibiotic-resistant bacteria at the surgical site. D-PLEX(100) received Breakthrough Therapy Designation from the U.S. FDA for the prevention of SSIs in patients undergoing elective colorectal surgery. D-PLEX(100) also received three Qualified Infectious Disease Product (QIDP) designations, and three Fast Track designations for the prevention of SSIs in patients undergoing elective colorectal surgery, post-abdominal surgery incisional infection and for the prevention of sternal wound infection post-cardiac surgery.공시 • Jun 23PolyPid Ltd. Announces Recruitment of First Patient in Revised Shield Ii Phase 3 Trial Evaluating D-Plex100 for Prevention of Abdominal Colorectal Surgical Site InfectionsPolyPid Ltd. announced that the first patient has been recruited and is scheduled for surgery in its revised SHIELD II Phase 3 trial evaluating D-PLEX100 for the prevention of abdominal colorectal surgical site infections (SSIs). The U.S. Food and Drug Administration (FDA) recently accepted the Company's revised protocol for SHIELD II, which is recruiting patients undergoing colorectal resection surgery with large incisions (> 20 cm). SHIELD II will enroll an estimated 550 additional patients beyond the 40 patients already recruited into the trial. Total recruitment time into the trial is anticipated to be approximately 12 months and top-line results are expected in mid-2024. PolyPid also intends to conduct an unblinded interim analysis once a total of approximately 400 patients complete their 30-day follow-up.공시 • Jun 06PolyPid Announces 180-Day Extension to Regain Compliance with Nasdaq Minimum Bid Requirement and Transfer of its Listing to the Nasdaq Capital MarketPolyPid Ltd. announced it has received an extension of the period to regain compliance with The Nasdaq Stock Market LLC’s ("Nasdaq") minimum bid price rule and approval from Nasdaq to transfer the listing of the ordinary shares of the Company (the “Ordinary Shares”) from The Nasdaq Global Market to The Nasdaq Capital Market. The transfer will become effective at the opening of business on June 6, 2023. As previously disclosed, on December 6, 2022, the Company received a letter from Nasdaq indicating that the Company was not in compliance with Nasdaq Listing Rule 5450(a)(1), as the closing bid price of its Ordinary Shares had been below $1.00 per Ordinary Share for the previous 30 consecutive business days. The Company was given a period of 180 calendar days, or until June 5, 2023, to regain compliance with the minimum bid price requirement. In order to be provided with a second 180-day compliance period, the Company submitted an application to transfer the listing of its Ordinary Shares from the Nasdaq Global Market to the Nasdaq Capital Market. The Company’s Ordinary Shares continue to trade under the symbol “PYPD” and trading of its Ordinary Shares will not be affected by this transfer. The Nasdaq Capital Market is a continuous trading market that operates in substantially the same manner as The Nasdaq Global Market. The approval of the second compliance period and the transfer to the Nasdaq Capital Market was based upon the Company meeting the applicable market value of publicly held shares requirement for continued listing and all other applicable requirements for initial listing on the Capital Market, except for the bid price requirement, the Company’s written notice of its intention to cure the deficiency by effecting a reverse stock split, if necessary, and additional supporting information provided in its application. In connection with the transfer to the Nasdaq Capital Market, Nasdaq granted the Company an additional 180-day period (or until December 4, 2023) to regain compliance with the requirement set in Nasdaq Listing Rule 5450(a)(1) that the bid price of the Company’s Ordinary Shares meet or exceed $1.00 per Ordinary Share for at least ten consecutive business days. If at any time during this additional time period the closing bid price of the Company’s security is at least $1.00 per share for a minimum of 10 consecutive business days, Nasdaq will provide written confirmation of compliance and this matter will be closed.공시 • May 23PolyPid Ltd Announces FDA Agreement on the Design of SHIELD II Phase 3 Trial Evaluating D-PLEX100 for Prevention of Abdominal Colorectal Surgical Site InfectionsPolyPid Ltd. announced that the U.S. Food and Drug Administration (FDA) agreed to Company’s SHIELD II Phase 3 trial design evaluating D-PLEX100 for the prevention of abdominal colorectal surgical site infections (SSIs). The revised SHIELD II trial will recruit patients undergoing colorectal resection surgery with large incisions (> 20 cm). Recruitment into the trial will resume imminently with the enrollment of an estimated 550 additional patients beyond the 40 patients already recruited into SHIELD II. Total recruitment time into the study is anticipated to be approximately 12 months and top-line results are expected in mid-2024. PolyPid also intends to conduct an unblinded interim analysis once a total of approximately 400 patients complete their 30-day follow-up. SHIELD II (Surgical site Hospital acquired Infection prEvention with Local D-PLEX) is a prospective, multinational, randomized, double blind Phase 3 trial designed to assess the efficacy and safety of D-PLEX100 administered concomitantly with standard of care (SoC), which includes prophylactic systemic antibiotics, compared to SoC alone arm, in the prevention of post abdominal-surgery incisional infection in patients undergoing surgeries with incisions greater than 20 cm. The primary endpoint of the trial is measured by the proportion of subjects with either an SSI event as determined by a blinded and independent adjudication committee, reintervention, or mortality for any reason within 30 days post-surgery. Patient safety will be monitored for an additional 30 days. The trial will enroll patients in centers in the United States, Europe and Israel.공시 • May 11+ 1 more updatePolyPid Ltd. Announces Board ChangesPolyPid Ltd. announced that appointment of Yossi BenAmram, former SVP and President of Merck & Co.’s Europe, Russia, Africa, and Middle East region, as an independent Director on the Company’s Board, replacing Mr. Chaim Hurvitz, a member of the Board since 2016, effective May 8, 2023.공시 • Feb 01PolyPid Ltd. to Report Q4, 2022 Results on Feb 08, 2023PolyPid Ltd. announced that they will report Q4, 2022 results Pre-Market on Feb 08, 2023공시 • Jan 25PolyPid Provides Positive Regulatory Update for D-PLEX100 for the Prevention of Surgical Site Infections in Abdominal Colorectal SurgeryPolyPid Ltd. provided a positive regulatory update for D-PLEX100 for the prevention of abdominal colorectal surgical site infections (SSIs). Following a recent type D meeting communication with the U.S. Food and Drug Administration (FDA) on the SHIELD I Phase 3 data, the Company now has clarity regarding the regulatory pathway toward a potential New Drug Application (NDA) submission. PolyPid provided to the FDA currently available data from the SHIELD I study evaluating D-PLEX100 for the prevention of abdominal colorectal SSIs. Based on the data, particularly the 54% reduction observed in the primary endpoint in complex surgeries in a pre-specified subgroup analysis of patients with large incisions (>20 cm) (p=0.0032, n=423) compared to standard of care, the FDA acknowledged that the SHIELD I results may provide supportive evidence on this population and recommended that the Company conduct an additional study to support a potential NDA submission. The FDA stated that the ongoing SHIELD II study, which to date has enrolled over 200 patients, could potentially serve as such a study. PolyPid is now working expeditiously to finalize the design of the revised SHIELD II trial and expects to resume patient recruitment next quarter.공시 • Jan 04Polypid Ltd. Announces Publication in the American Journal of Surgery of Phase 2 Clinical Trial Post-Hoc Analysis for D-PLEX in the Prevention of Surgical Site Infections in Abdominal SurgeryPolyPid Ltd. announced the peer-reviewed publication of a post-hoc analysis from the previously-completed Phase 2 study of D-PLEX100 for the prevention of surgical site infections (SSIs) in abdominal surgery. The paper, entitled, “Reduction in Surgical Site Infections by Localized Administration with D-PLEX100 in Patients with Multiple Risk Factors Undergoing Colorectal Surgery. The Phase 2 trial was a prospective, multicenter, randomized, controlled, single-blind, two arm study and was designed to assess the efficacy and the safety of D-PLEX100 in addition to standard of care (SoC) in preventing superficial and deep SSIs in patients undergoing elective colorectal surgery. This post-hoc analysis was intended to evaluate the effect of D-PLEX100 on SSI incidence in patients with multiple preoperative risk factors. Thirty-day SSI rates were examined in patients in the Intention-to-treat (ITT) population and in those with two or more patient related risk factors. Individual risk factor categories included diagnoses of diabetes, chronic obstructive pulmonary disease (COPD) or a history of smoking, obesity/overweight as defined as a body mass index (BMI) of 25 or more, hypertension, and peripheral vascular disease. The distribution of the assessed risk factors between the D-PLEX100 plus SoC and SoC cohorts was approximately even. Two hundred and one patients were evaluated in the ITT population, 101 in the intervention arm and 100 in the control arm. The study showed a 53% statistically significant relative risk reduction of the SSI rate (superficial and deep) within 30 days post-index surgery in the D-PLEX100 cohort (N=10/101 [9.9%]) compared to SoC (N=21/100 [21%]; p = 0.033). In patients with two or more risk factors, the SSI rate in the D-PLEX100 plus SOC cohort was 15.8% (6/38) compared to 37.5% (15/40) in the SOC alone cohort, demonstrating a statistically significant relative risk reduction of 58% (p = 0.042).공시 • Dec 13PolyPid Ltd. Announces Scheduling of Type D Meeting with U.S. FDA to Discuss SHIELD I Phase 3 Results and Regulatory Pathway for D-PLEX100 for the Prevention of Surgical Site Infections in Abdominal Colorectal SurgeryPolyPid Ltd. announced that a Type D meeting has been scheduled for January 2023 with the U.S. Food and Drug Administration (FDA) to discuss the results of SHIELD I Phase 3 study and regulatory requirements to support the indication of D-PLEX100 for the prevention of abdominal colorectal surgical site infections (SSIs). In advance of the meeting, PolyPid recently provided the FDA with currently available data from the completed SHIELD I study. The FDA established Type D meetings to provide an opportunity for companies to address more focused issues on a shorter timeline than other meeting types normally allow. A Type D meeting is focused on a narrow set of issues and is limited to no more than two focused topics. The FDA aims to conduct Type D meetings with companies within 50 calendar days after receipt of the meeting request.공시 • Dec 12PolyPid Announces Receipt of Nasdaq Minimum Bid Price NotificationPolyPid Ltd. announced that it has received a written notice (the "Notice") from Nasdaq Stock Market LLC ("Nasdaq") indicating that the Company is not in compliance with the minimum bid price requirement for continued listing set forth in Nasdaq Listing Rule 5550(a)(2), which requires listed securities to maintain a minimum bid price of $1.00 per share. Under Nasdaq Listing Rule 5810(c)(3)(A), the Company has been granted a period of 180 calendar days to regain compliance with the minimum bid price requirement. The Notice has no immediate effect on the Company's Nasdaq listing or the trading of its ordinary shares, and during the grace period, as may be extended, the Company's ordinary shares will continue to trade on Nasdaq. According to the Notice, the Company has until June 5, 2023 to regain compliance with the minimum bid price requirement. The Company can regain compliance, if at any time during this 180-day period, the closing bid price of its ordinary shares is at least $1.00 for a minimum of ten consecutive business days, in which case the Company will be provided with written confirmation of compliance and this matter will be closed. In the event that the Company does not regain compliance after the initial 180-day period, the Company may then be eligible for an additional 180-day compliance period if it meets the continued listing requirement for market value of publicly held shares and all other initial listing standards for The Nasdaq Capital Market, with the exception of the minimum bid price requirement. In this case, the Company will need to provide written notice of its intention to cure the deficiency during the second compliance period. If the Company cannot demonstrate compliance by the allotted compliance period(s), Nasdaq's staff will notify the Company that its ordinary shares are subject to delisting.Price Target Changed • Nov 16Price target decreased to US$3.38Down from US$21.50, the current price target is an average from 4 analysts. New target price is 321% above last closing price of US$0.80. Stock is down 89% over the past year. The company is forecast to post a net loss per share of US$1.94 next year compared to a net loss per share of US$2.28 last year.공시 • Oct 27PolyPid Ltd. to Report Q3, 2022 Results on Nov 09, 2022PolyPid Ltd. announced that they will report Q3, 2022 results at 9:30 AM, US Eastern Standard Time on Nov 09, 2022Seeking Alpha • Oct 20PolyPid set to cut 20% jobsPolyPid (NASDAQ:PYPD) announced on Thursday a cost reduction plan, including a 20% job cut across all departments as it expects the actions to extend tits cash runway into Q3 2023. The company expects to discuss regulatory pathway for D-PLEX100 for prevention of surgical site infections in abdominal surgery with U.S. and EU regulatory authorities in Q1 2023. As of February 28, the company had 78 full-time employees.공시 • Sep 29Polypid Ltd. Announces Eligibility for European Medicines Agency Centralized Procedure for D-Plex100 for the Prevention of Surgical Site Infections in Abdominal SurgeryPolyPid Ltd. announced that it has received confirmation from the European Medicines Agency (EMA) that D-PLEX100 is eligible for submission of a Marketing Authorization Application (MAA) in the European Union (EU) under the Agency’s centralized procedure. The centralized procedure allows the submission of a single marketing application to the EMA that, if approved, enables the product to be marketed in all EU member states as well as in Iceland, Liechtenstein and Norway. The centralized process eligibility is granted to D-PLEX100 under the Therapeutic Innovation criteria which underscores that D-PLEX100 provides a new alternative to patients in preventing post abdominal surgical site infections (SSIs).Seeking Alpha • Sep 28PolyPid's surgical site infections treatment eligible for marketing nod submission in EUPolyPid (NASDAQ:PYPD) on Wednesday said it had got confirmation from Europe's drug regulator that its D-PLEX100 product candidate for the treatment of surgical site infections was eligible to be submitted for a marketing authorization. The company said the product candidate was eligible for the European Medicines Agency's (EMA) centralized procedure under the therapeutic innovation criteria. "The centralized procedure allows the submission of a single marketing application to the EMA that, if approved, enables the product to be marketed in all EU member states as well as in Iceland, Liechtenstein and Norway," PYPD said in a statement. The company is currently evaluating its recently concluded phase 3 trial which evaluated D-PLEX100 for the prevention of surgical site infections in abdominal surgery. PYPD said it intends to discuss the data from the late-stage trial and potential next steps with U.S. and EU regulators in Q1 2023. PolyPid (PYPD) stock +1.2% to $1.10 in morning trading.공시 • Sep 20PolyPid Announces Peer-Reviewed Publication of Phase 2 Clinical Trial Results for D-PLEX100 in the Prevention of Surgical Site Infections in Abdominal SurgeryPolyPid Ltd. announced the peer-reviewed publication of positive clinical data from the previously completed Phase 2 study of D-PLEX100 for the prevention of surgical site infections (SSIs) in abdominal surgery. The paper, entitled, “A prospective, randomized assessment of a novel, local antibiotic releasing platform for the prevention of superficial and deep surgical site infections,” was published in Techniques in Coloproctology, and can be found here. The Phase 2 trial was a prospective, multicenter, randomized, controlled, single-blind, two arm study and was designed to assess the efficacy and the safety of D-PLEX100 in addition to standard of care (SoC) in preventing superficial and deep SSIs in patients undergoing elective colorectal surgery. Efficacy was measured by the incidence of SSIs and mortality within 30 days post-surgery. SSIs were adjudicated by the endpoint adjudication committee, all of whom were blinded to study-group assignments. In addition, safety was assessed by the stratification and incidence of treatment-emergent adverse events. One hundred and seventy-nine patients were evaluated in the per protocol population, 88 in the intervention arm [51 males, 37 females, median age 64.0 (range: 19–92) years] and 91 in the control arm [57 males, 34 females, median age 64.5 (range: 21–88) years]. The SSI rate (superficial and deep) within 30 day post-index surgery showed a 64% statistically significant relative risk reduction in the D-PLEX100 plus SoC cohort at 8% infection rate [n=7/88] compared to 22% infection rate in the SoC alone cohort [n=20/91] (p=0.0115). There was no statistically significant difference in the incidence of treatment-emergent adverse events (TEAEs) between the two groups, and no difference in severity and incidence of serious TEAEs. No TEAEs in the D-PLEX100 plus SoC cohort were deemed related to the study drug. The appropriate next steps for PolyPid’s second Phase 3 trial of D-PLEX100 for the prevention of SSIs in abdominal surgery, SHIELD II, which incorporates broader eligibility criteria and has enrolled over 200 subjects to date, will be evaluated following the discussion with the FDA and the EU regulatory authorities. D-PLEX100, PolyPid’s lead product candidate, is designed to provide local prolonged and controlled anti-bacterial activity directly at the surgical site to prevent SSIs. Following the administration of D-PLEX100 into the surgical site, the PLEX (Polymer-Lipid Encapsulation matriX) technology pairs with Active Pharmaceutical Ingredients, enabling a prolonged and continuous release of the broad-spectrum antibiotic doxycycline, resulting in high local concentration of the drug for a period of 30 days for the prevention of SSIs, with additional potential to prevent SSIs caused by antibiotic-resistant bacteria at the surgical site. D-PLEX100 received Breakthrough Therapy Designation from the U.S. FDA for the prevention of SSIs in patients undergoing elective colorectal surgery. D-PLEX100 also received three Qualified Infectious Disease Product (QIDP) designations, and three Fast Track designations for the prevention of SSIs in patients undergoing elective colorectal surgery, post-abdominal surgery incisional infection and for the prevention of sternal wound infection post-cardiac surgery.Price Target Changed • Sep 06Price target increased to US$24.33Up from US$21.50, the current price target is an average from 3 analysts. New target price is 2,016% above last closing price of US$1.15. Stock is down 86% over the past year. The company is forecast to post a net loss per share of US$2.04 next year compared to a net loss per share of US$2.28 last year.공시 • Sep 04PolyPid Ltd. Announces Top-line Results of Phase 3 SHIELD I Trial of D-PLEX for the Prevention of Surgical Site Infections in Abdominal SurgeryPolyPid Ltd. announced top-line results from the SHIELD I Phase 3 study of D-PLEX(100) for the prevention of surgical site infections (SSIs) in abdominal surgery. SHIELD I (Surgical site Hospital acquired Infection prEvention with Local D-PLEX(100)) is a prospective, multinational, randomized, double-blind Phase 3 trial designed to assess the efficacy and safety of D-PLEX(100) administered concomitantly with standard of care (SoC) compared to a SoC alone arm, in the prevention of post-abdominal surgery incisional infection. The primary endpoint of the trial is the combination of incisional SSIs and mortality as measured by the proportion of subjects with either an SSI event, as determined by a blinded and independent adjudication committee, or mortality for any reason within 30 days post-surgery. The SHIELD I study is designed to demonstrate at least a 50 percent reduction in incisional SSIs in the D-PLEX(100) treatment arm compared to the control arm, with 90 percent power and a maximum alpha level of 0.0487. A total of 977 patients were randomized into the study, consisting of 488 subjects in the D-PLEX(100) treatment arm and 489 patients in the control arm. In the Intent to Treat (ITT) population, the local administration of D-PLEX(100) and SoC (n=485) resulted in a decrease in SSIs and mortality of 23 percent compared to SoC alone (n=489) (p=0.1520). Within the first 30 days post- surgery, there were 15 deaths in the SoC treatment arm, as compared to 11 in the D-PLEX(100) treatment arm. The local administration of D-PLEX(100) as compared to SoC alone also did not achieve statistical significance on the key secondary endpoint evaluating SSI events within 30 days post-abdominal index surgery. In a pre-specified subgroup ITT analysis requested by the U.S. Food and Drug Administration (FDA) of a total of 423 subjects with incision lengths >20 centimeters, the local administration of D-PLEX(100) resulted in a statistically significant reduction of 54% on the primary endpoint, compared to SoC alone (p<0.0032). Within the first 30 days post-surgery, SSIs decreased from 8.5% in the SoC treatment arm (n=211), as compared to 4.2% in the D-PLEX(100) treatment arm (n=212).Seeking Alpha • Sep 02PolyPid sheds 75% as lead candidate fails in Phase 3 trial for post-surgical infectionsPolyPid Ltd. (NASDAQ:PYPD) dropped ~75% in value in the pre-market trading Friday after the Israeli company announced that its lead candidate D-PLEX100 did not meet the main goal in a Phase 3 trial for the prevention of surgical site infections ((SSIs)) in abdominal surgery. The SHIELD I was designed to evaluate the joint administration of D-PLEX100 standard of care (SoC) against SoC alone arm in 970 patients out of whom 488 were part of the D-PLEX100 treatment arm and 489 were in the control arm. The trial did not achieve the primary endpoint of reduction in surgical site infections and mortality, the company said noting that in the Intent to Treat (ITT) population, D-PLEX100 and SoC (n=485) led to 23% decrease in SSIs and mortality compared to SoC alone (n=489) (p=0.1520).Seeking Alpha • Aug 10PolyPid GAAP EPS of -$1.23 misses by $0.60PolyPid press release (NASDAQ:PYPD): Q2 GAAP EPS of -$1.23 misses by $0.60. As of June 30, 2022, the Company had cash and cash equivalents and deposits in the amount of $23.8 million, not including the second tranche of $2.5 million from the Kreos Capital VI (Expert Fund) LP (“Kreos”) loan, which was drawn in July 2022.Seeking Alpha • Aug 03PolyPid to get $2.6M upfront under license deal with Advanz for D-PLEX in EuropePolyPid (NASDAQ:PYPD) signed an exclusive licensing agreement for its lead drug candidate D-PLEX100 in Europe with U.K.-based Advanz Pharma (OTCPK:CXRXF). D-PLEX100 is used for preventing surgical site infections (SSIs) in abdominal and cardiac surgeries, in Europe. Under the agreement, PolyPid will receive $2.6M upfront and development-related milestones of up to $20.9M. Upon commercialization, PolyPid will receive up to $89M in sales-related milestones, the company said in an Aug. 3 press release. In addition, PolyPid will also supply D-PLEX100 to Advanz for a transfer price and will be entitled to royalties on net sales in double-digit percentages of up to mid-twenties. "Advanz Pharma's expertise in marketing hospital-based therapies, combined with its significant resources and relationships in the region, will prove invaluable in expanding access to D-PLEX100 and delivering this much-needed therapy, if approved, to patients," said PolyPid's CEO Dikla Czaczkes Akselbrad.공시 • Jul 28PolyPid Ltd. to Report Q2, 2022 Results on Aug 10, 2022PolyPid Ltd. announced that they will report Q2, 2022 results Pre-Market on Aug 10, 2022공시 • Jun 01Polypid Ltd Announces Completion of Enrollment in Phase 3 Shield I Trial of D-Plex for Prevention of Surgical Site Infections in Abdominal SurgeryPolyPid Ltd. announced the completion of enrollment in the SHIELD I Phase 3 study of D-PLEX100 for the prevention of surgical site infections (SSIs) in abdominal surgery. Following a review of unblinded efficacy data from the first 750 enrolled patients in the trial, the independent Data Safety Monitoring Board (DSMB) recently recommended concluding the study upon enrollment of 950 patients, which is the minimum number of targeted patients in the trial protocol. About SHIELD I SHIELD I (Surgical site Hospital acquired Infection prEvention with Local D-PLEX) is a prospective, multinational, randomized, double blind Phase 3 trial designed to assess the efficacy and safety of D-PLEX100 administered concomitantly with standard of care (SoC), which includes prophylactic systemic antibiotics, compared to a SoC alone arm, in prevention of post abdominal surgery incisional infection. The primary endpoint of the trial is the combination of incisional SSIs and mortality rate as measured by the proportion of subjects with either an SSIs event, as determined by a blinded and independent adjudication committee, or mortality for any reason within 30 days post-surgery. The trial has enrolled patients in more than 60 centers in the United States, Europe and Israel. About D-PLEX100 D-PLEX100, PolyPid’s lead product candidate, is designed to provide local prolonged and controlled anti-bacterial activity directly at the surgical site to prevent SSIs. Following the administration of D-PLEX100 into the surgical site, the PLEX (Polymer-Lipid Encapsulation matriX) technology pairs with Active Pharmaceutical Ingredients, enabling a prolonged and continuous release of the broad-spectrum antibiotic doxycycline, resulting in high local concentration of the drug for a period of 30 days for the prevention of SSIs, with additional potential to prevent SSIs caused by antibiotic-resistant bacteria at the surgical site. D-PLEX100 received Breakthrough Therapy Designation from the U.S. FDA for the prevention of SSIs in patients undergoing elective colorectal surgery. D-PLEX100 also received three Qualified Infectious Disease Product (QIDP) designations, and three Fast Track designations for the prevention of SSIs in patients undergoing elective colorectal surgery, post-abdominal surgery incisional infection and for the prevention of sternal wound infection post-cardiac surgery.공시 • May 24PolyPid Ltd. Announces Recommendation by Data Safety Monitoring Board to Conclude Enrollment of Phase 3 SHIELD I Trial of D-PLEX at the Minimum Number of Patients Targeted Following Unblinded Interim Efficacy AnalysisPolyPid Ltd. announced that following the independent Data Safety Monitoring Board (DSMB) review of unblinded efficacy data from the first 750 enrolled patients in the SHIELD I Phase 3 study of D-PLEX100 for the prevention of surgical site infections (SSIs) in abdominal tissue surgery, the recommendation was to conclude the study upon enrollment of 950 patients, which is the minimum number of targeted patients in the study protocol. The enrollment of the 950th patient is expected to occur within days. The SHIELD I study is designed to demonstrate at least a 50% reduction in incisional SSIs in the D-PLEX100 treatment arm compared to the control arm, with 90% power and a maximum alpha level of 0.04. The Company anticipates reporting top-line results by the end of the third quarter of 2022, followed by a potential New Drug Application (NDA) submission to the U.S. Food and Drug Administration (FDA) and a European Union Marketing Authorization Application (MAA) filing, both targeted for the first half of 2023. SHIELD I (Surgical site Hospital acquired Infection prEvention with Local D-PLEX) is a prospective, multinational, randomized, double blind Phase 3 trial designed to assess the efficacy and safety of D-PLEX100 administered concomitantly with standard of care (SoC), which includes prophylactic systemic antibiotics, compared to a SoC alone arm, in prevention of post abdominal surgery incisional infection. The primary endpoint of the trial is the combination of incisional SSIs and mortality rate as measured by the proportion of subjects with either an SSIs event, as determined by a blinded and independent adjudication committee, or mortality for any reason within 30 days post-surgery. The trial has enrolled patients in more than 60 centers in the United States, Europe and Israel. D-PLEX100, PolyPid’s lead product candidate, is designed to provide local prolonged and controlled anti-bacterial activity directly at the surgical site to prevent SSIs. Following the administration of D-PLEX100 into the surgical site, the PLEX (Polymer-Lipid Encapsulation matriX) technology pairs with Active Pharmaceutical Ingredients, enabling a prolonged and continuous release of the broad-spectrum antibiotic doxycycline, resulting in high local concentration of the drug for a period of four weeks for the prevention of SSIs, with additional potential to prevent SSIs caused by antibiotic-resistant bacteria at the surgical site. D-PLEX100 received Breakthrough Therapy Designation from the U.S. FDA for the prevention of SSIs in patients undergoing elective colorectal surgery. D-PLEX100 also received three Qualified Infectious Disease Product (QIDP) designations, and three Fast Track designations for the prevention of SSIs in patients undergoing elective colorectal surgery, post-abdominal surgery incisional infection and for the prevention of sternal wound infection post-cardiac surgery.공시 • May 12PolyPid Ltd. Announces Executive ChangesPolyPid Ltd. strengthened the executive management team with the recent appointment of Evgeny Valdman as Company's new Executive Vice President of Operations and the promotion of Dalit Hazan to Executive Vice President, Research & Development, and Clinical & Regulatory Affairs. Evgeny brings to PolyPid more than 25 years of experience in senior management positions at Teva Pharmaceuticals and other pharmaceutical companies with approved products, with success at all levels of operations. Since 2016, Ms. Hazan has served in various leadership roles at PolyPid, most recently as PolyPid’s Senior Vice President, Research and Development and Regulatory Affairs.Seeking Alpha • Apr 19PolyPid: Strong Pipeline, Close CatalystsPolyPid develops a platform technology to provide locally controlled and continuous delivery of medications. Lead product candidate D-PLEX100 is investigated for the prevention of sternal and abdominal surgical site infections serving a huge market. Meaningful interim results and topline data from pivotal Phase 3 SHIELD I clinical trial will soon be published. Measured in terms of the clinical benefit of D‑PLEX100 and its estimated market size, PolyPid is clearly undervalued at present in our view.공시 • Apr 07PolyPid Ltd. announced that it expects to receive $15 million in funding from Kreos Capital Management (UK) LimitedPolyPid Ltd. entered into a secured loan agreement with new lender Kreos Capital VI (Expert Fund) L.P., a fund managed by Kreos Capital Management (UK) Limited for up to $15 million on April 6, 2022. The loan facility is comprised of three tranches in the amount of $10 million, $2.5 million, and $2.5 million, respectively, with the completion of the first tranche available upon the execution of the agreement. The second tranche of $2.5 million will be available subject to obtaining positive results from the planned unblinded interim analysis of the company’s ongoing Phase 3 trial of D-PLEX100 for the prevention of abdominal soft tissue SSIs, SHIELD I, which will be conducted following the 30-day follow-up assessment for the recently enrolled 750th patient that is expected in the second quarter of this year. Completion of the third and final tranche of $2.5 million will be available subject to obtaining positive top-line results from the SHIELD I trial or if other conditions are met. Completion of the second and third tranches can be made by December 31, 2022. The loan agreement provides for interest-only repayments of the first tranche until December 31, 2022, followed by 36 equal monthly repayments of principal and interest. For the second and third tranches, if drawn, the company will make repayments of interest only until August 31, 2023, followed by 33 equal monthly repayments of principal and interest. The senior secured loan initially bears interest at a rate of 9.25%, which may be reduced to 8.75% upon reaching certain milestones. The loan is prepay able in full, at any time at the option of the company. The company will also issue a 7-year warrant to the investor to purchase the company’s ordinary shares equal to 8% of the amount of each tranche, if borrowed, with an exercise price of $5.135 per share.공시 • Mar 29PolyPid Ltd., Annual General Meeting, May 03, 2022PolyPid Ltd., Annual General Meeting, May 03, 2022, at 11:00 Israel Standard Time. Location: 18 Hasivim Street, Petach 495376 Tikva Israel Agenda: To re-appoint Kost Forer Gabbay & Kasierer, Certified Public Accountants, as the independent registered public accountants of the company, and to authorize the board of directors of the company to determine their compensation; to re- elect seven members of the board of directors of the company and approve their compensation; to approve an option grant and a retirement package for the company’s currently serving Chief Executive Officer, Mr. Amir Weisberg; to approve the terms of employment for Ms. Dikla Czaczkes Akselbrad as the company’s new Chief Executive Officer; to approve an amendment to the company's Articles of Association; to discuss the company’s financial statements for the fiscal year ended December 31, 2021.분석 기사 • Mar 18Will PolyPid (NASDAQ:PYPD) Spend Its Cash Wisely?We can readily understand why investors are attracted to unprofitable companies. For example, biotech and mining...공시 • Mar 04PolyPid Ltd. Announces 750Th Patient Enrolled in Shield I Phase 3 Clinical Trial of D-Plex100 in Abdominal SurgeryPolyPid Ltd. announced that the 750th patient has been enrolled into its ongoing pivotal Phase 3 SHIELD I study evaluating D-PLEX100 for the prevention of surgical site infections (SSIs) in abdominal surgery. Upon completion of the 30-day follow-up assessment for the 750th patient, based on an agreement with the U.S. Food and Drug Administration (FDA), an unblinded interim analysis will be conducted. This interim analysis is expected to occur during the second quarter of this year, and will allow for early trial conclusion due to efficacy, futility, or for sample size re-assessment. The FDA has previously agreed, provided the Phase 3 study results are adequate, that a single pivotal study is sufficient for potential approval of D-PLEX100 for the prevention of SSIs in colorectal (abdominal) surgery.공시 • Feb 10PolyPid Ltd. Announces CEO ChangesPolyPid Ltd. announced that Board of Directors appointed Dikla Czaczkes Akselbrad, currently Executive Vice President and Chief Financial Officer of the Company, as PolyPid’s Chief Executive Officer, effective July 1, 2022, at which time Amir Weisberg will retire from his position as Chief Executive Officer.분석 기사 • Nov 08Here's Why We're Watching PolyPid's (NASDAQ:PYPD) Cash Burn SituationWe can readily understand why investors are attracted to unprofitable companies. For example, although...공시 • Sep 15PolyPid Announces Positive Preclinical Data of its Intra-tumoral OncoPLEX in Brain CancerPolyPid Ltd. announced positive preclinical data in two key Glioblastoma Multiform (GBM) animal models of its OncoPLEX intra-tumoral cancer therapy program. OncoPLEX utilizes the Company’s novel PLEX technology to provide controlled local exposure to docetaxel, one of the most widely used chemotherapy agents, for a few weeks in the intra-operative tumor resection setting, to potentially reduce local tumor recurrence, tumor spreading and prolong patient survival. The OncoPLEX intra-tumoral cancer therapy program was evaluated in brain tumors for tumor growth and survival in two Glioblastoma Multiform (GBM) animal models. Key results included: OncoPLEX induced strong inhibition of tumor growth and recurrence in a partially resected human glioblastoma subcutaneous mouse model. A single local OncoPLEX application induced 98% tumor growth inhibition (day 41 post operation) compared to the untreated control (p<0.001), and 66% compared to multiple injections of systemic chemotherapy treatment arm (p=0.0165). The day 41 survival rate for OncoPLEX was much higher than the systemic treated mice, or untreated with 60%, 20%, and 10% survival, respectively. OncoPLEX was also tested in a GBM brain rat model. OncoPLEX, applied locally next to the non-resected tumor in the brain, showed a 40% survival rate at day 23 following the beginning of treatment, as compared to a 0% survival rate in the standard systemic treatment arm (Temozolomide 33.5 mg/kg, 5 treatment days), the placebo arm (OncoPLEX without Docetaxel) and in the untreated control arm. Only OncoPLEX significantly enhanced the overall survival compared to both the placebo arm and to the untreated arm (p<0.02). Dose response was demonstrated for OncoPLEX in the different animal models. Local application of OncoPLEX in a rat brain model evidenced good safety profile at the different doses studied.분석 기사 • Jul 15We Think PolyPid (NASDAQ:PYPD) Can Afford To Drive Business GrowthThere's no doubt that money can be made by owning shares of unprofitable businesses. For example, although...공시 • May 20PolyPid Ltd. Announces Positive FDA Type B Meeting Feedback for D-Plex Development ProgramPolyPid Ltd. announced it has received written responses from the U.S. Food and Drug Administration (FDA) to a Type B meeting request that the Company submitted regarding its development plan for D-PLEX100. The FDA indicated that PolyPid’s proposal for a single Phase 3 pivotal study (SHIELD I), provided the study results are adequate, would provide sufficient evidence of clinical efficacy and safety to support approval of D-PLEX100 for the prevention of surgical site infections (SSIs) in colorectal surgery. The Type B meeting was requested following PolyPid’s receipt of Breakthrough Therapy Designation from the FDA for D-PLEX100 for the prevention of SSIs in patients undergoing elective colorectal surgery. Launched in July 2020, SHIELD I is a prospective, multinational, multicenter, randomized, double blind Phase 3 trial designed to assess the efficacy and safety of D-PLEX100 for the prevention of incisional SSIs post-abdominal surgery. The primary endpoint of the trial is the combination of incisional SSIs and mortality rate as measured by the proportion of subjects with either an SSI event, as determined by a blinded and independent adjudication committee, or mortality for any reason within 30 days post-surgery. The trial will enroll a minimum of 616 patients, with a maximum of about 900 patients, as defined by the adaptive study design, in more than 60 centers in the United States, Europe and Israel.분석 기사 • Mar 09Here's Why We're Not Too Worried About PolyPid's (NASDAQ:PYPD) Cash Burn SituationEven when a business is losing money, it's possible for shareholders to make money if they buy a good business at the...공시 • Mar 06PolyPid Ltd., Annual General Meeting, Apr 13, 2021PolyPid Ltd., Annual General Meeting, Apr 13, 2021, at 11:00 Israel Standard Time. Location: 18 Hasivim Street Petach Tikva Israel Agenda: To re-appoint Kost Forer Gabbay & Kasierer, Certified Public Accountants (Isr.), a member firm of EY Global, as independent registered public accountants of the Company; to re-appoint nine members of the Board of Directors of the Company; to approve a bonus and certain terms of compensation of Mr. Amir Weisberg, the Company’s Chief Executive Officer and director; to approve an increase in the annual fee of the Chairman of the Board of Directors; and to consider other matters.공시 • Feb 18Polypid Ltd. Announces 100Th Patient Enrolled in Shield I Phase 3 Clinical Trial of D-Plex100 for the Prevention of Post-Abdominal Surgery Incisional InfectionsPolyPid Ltd. announced that the 100th patient has been enrolled and randomized in the SHIELD I (Surgical site Hospital acquired Infection prEvention with Local D-plex) trial, the Company’s first of two Phase 3 clinical trials for its lead product candidate, D-PLEX100, for the prevention of post-abdominal surgery incisional infections (soft tissue). SHIELD I is a prospective, multinational, multicenter, randomized, double blind Phase 3 trial designed to assess the efficacy and safety of D-PLEX100 in the prevention of incisional surgical site infections (SSIs) post-abdominal surgery. The primary endpoint of the trial is the combination of incisional SSIs and mortality rate as measured by the proportion of subjects with either an SSIs event, as determined by a blinded and independent adjudication committee, or mortality for any reason within 30 days post-surgery. The trial will enroll a minimum of 616 patients, with a maximum of about 900 patients, as defined by the adaptive study design, in more than 60 centers in the United States, Europe and Israel.Is New 90 Day High Low • Feb 10New 90-day high: US$12.75The company is up 34% from its price of US$9.51 on 11 November 2020. The American market is up 15% over the last 90 days, indicating the company outperformed over that time. It also outperformed the Pharmaceuticals industry, which is up 8.0% over the same period.공시 • Jan 28PolyPid Ltd. to Report Q4, 2020 Results on Feb 10, 2021PolyPid Ltd. announced that they will report Q4, 2020 results Pre-Market on Feb 10, 2021공시 • Dec 23PolyPid Announces Positive Preclinical Data from OncoPLEX Intra-Tumoral Cancer Therapy ProgramPolyPid Ltd. announced positive preclinical data from its OncoPLEX intra-tumoral cancer therapy program. OncoPLEX utilizes the Company’s novel PLEX technology to provide prolonged and controlled local exposure to docetaxel, one of the most widely used chemotherapy agents, in the intra-operative tumor resection setting. OncoPLEX is designed for the delivery of sustained, significant concentrations of docetaxel locally within the tumor site for a few weeks, potentially reducing local tumor recurrence and tumor metastatic spreading. In a syngeneic mouse model for solid tumors of colon carcinoma, a single local application of OncoPLEX at the intra-operative setting post tumor resection compared to the group treated with six cycles of systemic docetaxel treatment with 2-4 days gap between cycles, generated the following key results: OncoPLEX arm showed 25% overall tumor recurrence at the end of the study (day 39 post-surgery) compared to 75% in the systemic treatment arm, and 100% in the untreated control arm. OncoPLEX arm demonstrated 75% overall tumor free survival at the end of the study (day 39 post-surgery), compared to 25% in the systemic treatment arm, and 0% in the untreated control arm. OncoPLEX arm demonstrated 75% overall survival at the end of the study (day 39 post-surgery), compared to 50% in the systemic treatment arm, and 0% in the untreated control arm. Dose response was also demonstrated for OncoPLEX in these studies. Systemic toxicity was lower following the local application of OncoPLEX versus systemic docetaxel. Additional data in a pharmacokinetic model showed that the maximal plasma concentration of docetaxel was >10 times lower with OncoPLEX than with systemic docetaxel. Based on these compelling preclinical results, PolyPid intends to conduct additional preclinical safety studies of OncoPLEX in various type of solid tumor resections, in order to complete a preclinical package for the filing of pre-Investigational New Drug meeting request with the U.S. Food and Drug Administration in 2021 and potentially initiate a Phase 1 clinical trial in 2022.공시 • Dec 18PolyPid Initiates SHIELD II: Second Phase 3 Clinical Trial of D-PLEX100 for the Prevention of Post-Abdominal Surgery Incisional InfectionsPolyPid Ltd. announced that the first patient has been enrolled and randomized in the SHIELD II (Surgical site Hospital acquired Infection prEvention with Local D-plex) trial, the Company’s second of two Phase 3 clinical trials for its lead product candidate, D-PLEX100, for the prevention of post-abdominal surgery incisional infection (soft tissue). SHIELD II (NCT04411199) is a prospective, multinational, multicenter, randomized, double-blind Phase 3 trial designed to assess the efficacy and safety of D-PLEX100 administered concomitantly with the Standard of Care (SoC), compared to a SoC-treated control arm, for the prevention of post-abdominal surgery incisional infection. The primary endpoint of the trial is the infection rate, as measured by the proportion of subjects with at least one abdominal target incisional infection event within 30 days post-abdominal surgery, determined by a blinded independent adjudication committee. The trial will enroll a minimum of 900 patients, with a maximum of approximately 1,400 subjects, as defined by the adaptive study design, in approximately 60 centers in the United States, Europe and Israel.Is New 90 Day High Low • Nov 07New 90-day low: US$9.98The company is down 30% from its price of US$14.21 on 07 August 2020. The American market is up 6.0% over the last 90 days, indicating the company underperformed over that time. It also underperformed the Pharmaceuticals industry, which is down 2.0% over the same period. According to the Simply Wall St valuation model, the estimated intrinsic value of the company is per share.공시 • Oct 29PolyPid Ltd. to Report Q3, 2020 Results on Nov 11, 2020PolyPid Ltd. announced that they will report Q3, 2020 results at 9:00 AM, Israel Standard Time on Nov 11, 2020Is New 90 Day High Low • Sep 28New 90-day low: US$11.00The company is down 39% from its price of US$18.03 on 30 June 2020. The American market is up 9.0% over the last 90 days, indicating the company underperformed over that time. It also underperformed the Pharmaceuticals industry, which is up 4.0% over the same period. According to the Simply Wall St valuation model, the estimated intrinsic value of the company is per share.공시 • Aug 07PolyPid Ltd. to Report Q2, 2020 Results on Aug 19, 2020PolyPid Ltd. announced that they will report Q2, 2020 results at 9:00 AM, Israel Standard Time on Aug 19, 2020매출 및 비용 세부 내역PolyPid가 돈을 벌고 사용하는 방법. 최근 발표된 LTM 실적 기준.순이익 및 매출 추이NasdaqCM:PYPD 매출, 비용 및 순이익 (USD Millions)날짜매출순이익일반관리비연구개발비31 Mar 260-34102331 Dec 250-3492430 Sep 250-3482530 Jun 250-3572531 Mar 250-3152431 Dec 240-2952330 Sep 240-2752030 Jun 240-2551831 Mar 240-2461731 Dec 230-2471630 Sep 230-2471630 Jun 230-2881931 Mar 230-34102331 Dec 220-40112830 Sep 220-46133330 Jun 220-47133431 Mar 220-46133331 Dec 210-43133130 Sep 210-41112630 Jun 210-37112331 Mar 210-46112031 Dec 200-4391730 Sep 200-4281530 Jun 200-3761531 Mar 200-1951431 Dec 190-1341431 Dec 180061331 Dec 170-5941030 Sep 170-203931 Dec 160-1438양질의 수익: PYPD 은(는) 현재 수익성이 없습니다.이익 마진 증가: PYPD는 현재 수익성이 없습니다.잉여현금흐름 대비 순이익 분석과거 순이익 성장 분석수익추이: PYPD는 수익성이 없지만 지난 5년 동안 연평균 8.7%의 속도로 손실을 줄였습니다.성장 가속화: 현재 수익성이 없어 지난 1년간 PYPD의 수익 성장률을 5년 평균과 비교할 수 없습니다.수익 대 산업: PYPD은 수익성이 없어 지난 해 수익 성장률을 Pharmaceuticals 업계(-4.8%)와 비교하기 어렵습니다.자기자본이익률높은 ROE: PYPD는 현재 수익성이 없으므로 자본 수익률이 음수(-383.02%)입니다.총자산이익률투하자본수익률우수한 과거 실적 기업을 찾아보세요7D1Y7D1Y7D1YPharmaceuticals-biotech 산업에서 과거 실적이 우수한 기업.View Financial Health기업 분석 및 재무 데이터 상태데이터최종 업데이트 (UTC 시간)기업 분석2026/05/26 20:09종가2026/05/26 00:00수익2026/03/31연간 수익2025/12/31데이터 소스당사의 기업 분석에 사용되는 데이터는 S&P Global Market Intelligence LLC에서 제공됩니다. 아래 데이터는 이 보고서를 생성하기 위해 분석 모델에서 사용됩니다. 데이터는 정규화되므로 소스가 제공된 후 지연이 발생할 수 있습니다.패키지데이터기간미국 소스 예시 *기업 재무제표10년손익계산서현금흐름표대차대조표SEC 양식 10-KSEC 양식 10-Q분석가 컨센서스 추정치+3년재무 예측분석가 목표주가분석가 리서치 보고서Blue Matrix시장 가격30년주가배당, 분할 및 기타 조치ICE 시장 데이터SEC 양식 S-1지분 구조10년주요 주주내부자 거래SEC 양식 4SEC 양식 13D경영진10년리더십 팀이사회SEC 양식 10-KSEC 양식 DEF 14A주요 개발10년회사 공시SEC 양식 8-K* 미국 증권에 대한 예시이며, 비(非)미국 증권에는 해당 국가의 규제 서식 및 자료원을 사용합니다.별도로 명시되지 않는 한 모든 재무 데이터는 연간 기간을 기준으로 하지만 분기별로 업데이트됩니다. 이를 TTM(최근 12개월) 또는 LTM(지난 12개월) 데이터라고 합니다. 자세히 알아보기.분석 모델 및 스노우플레이크이 보고서를 생성하는 데 사용된 분석 모델에 대한 자세한 내용은 당사의 Github 페이지에서 확인하실 수 있습니다. 또한 보고서 활용 방법에 대한 가이드와 YouTube 튜토리얼도 제공합니다.Simply Wall St 분석 모델을 설계하고 구축한 세계적 수준의 팀에 대해 알아보세요.산업 및 섹터 지표산업 및 섹터 지표는 Simply Wall St가 6시간마다 계산하며, 프로세스에 대한 자세한 내용은 Github에서 확인할 수 있습니다.분석가 소스PolyPid Ltd.는 8명의 분석가가 다루고 있습니다. 이 중 4명의 분석가가 우리 보고서에 입력 데이터로 사용되는 매출 또는 수익 추정치를 제출했습니다. 분석가의 제출 자료는 하루 종일 업데이트됩니다.분석가기관Balaji PrasadBarclaysBalaji PrasadBarclaysGary NachmanBMO Capital Markets Equity Research5명의 분석가 더 보기
공시 • May 06PolyPid Ltd. to Report Q1, 2026 Results on May 13, 2026PolyPid Ltd. announced that they will report Q1, 2026 results Pre-Market on May 13, 2026
공시 • Jan 28PolyPid Ltd. to Report Q4, 2025 Results on Feb 11, 2026PolyPid Ltd. announced that they will report Q4, 2025 results Pre-Market on Feb 11, 2026
공시 • Oct 29PolyPid Ltd. to Report Q3, 2025 Results on Nov 12, 2025PolyPid Ltd. announced that they will report Q3, 2025 results at 9:30 AM, US Eastern Standard Time on Nov 12, 2025
공시 • Jul 30PolyPid Ltd. to Report Q2, 2025 Results on Aug 13, 2025PolyPid Ltd. announced that they will report Q2, 2025 results Pre-Market on Aug 13, 2025
공시 • Apr 29PolyPid Ltd. to Report Q1, 2025 Results on May 14, 2025PolyPid Ltd. announced that they will report Q1, 2025 results at 9:30 AM, US Eastern Standard Time on May 14, 2025
공시 • Jan 29PolyPid Ltd. to Report Q4, 2024 Results on Feb 12, 2025PolyPid Ltd. announced that they will report Q4, 2024 results Pre-Market on Feb 12, 2025
공시 • May 06PolyPid Ltd. to Report Q1, 2026 Results on May 13, 2026PolyPid Ltd. announced that they will report Q1, 2026 results Pre-Market on May 13, 2026
공시 • Apr 29PolyPid Ltd Presents Data From SHIELD II Phase 3 Trial Demonstrating Reduced Severity Of Surgical Site InfectionPolyPid Ltd. announced that it will present at the 45th Annual Meeting of the Surgical Infection Society, taking place on May 5-6, 2026, at the Coronado Island Marriott in Coronado, California. The presentation will focus on a detailed analysis of the ASEPSIS (Additional treatment, Serous discharge, Erythema, Purulent exudate, Separation of deep tissues, Isolation of bacteria, and prolonged Stay as inpatient) score data from the Company's Phase 3 SHIELD II trial of D-PLEX100. The ASEPSIS score is a validated, objective clinical scoring system used to assess the severity of surgical wound infections. It integrates parameters such as wound appearance, antibiotic use, drainage of pus, isolation of pathogenic bacteria, and length of hospital stay. As previously reported in the SHIELD II topline results, treatment with D-PLEX100 together with the standard of care resulted in a 64% relative risk reduction (p=0.0103) in the proportion of patients with an ASEPSIS score greater than 20, the threshold indicative of clinically significant wound infection, compared to the standard of care alone. Surgical Infection Society 2026 Annual Meeting Presentation Details: Title: Evaluation of ASEPSIS Score as a Secondary Endpoint in the Phase 3 SHIELD II Trial of D-PLEX100 in Colorectal Surgery; Session: Scientific Session III; Date/Time: Wednesday, May 6, 2026 | 8:00 a.m. – 9:00 a.m. PT; Location: Coronado Island Marriott, Coronado, California. D-PLEX100, PolyPid’s lead product candidate, is designed to provide local prolonged and controlled anti-bacterial activity directly at the surgical site to prevent surgical site infections (“SSIs”). Following the administration of D-PLEX100 into the surgical site, PolyPid’s delivery technology, Kynatrix, pairs with Active Pharmaceutical Ingredients, enabling a prolonged and continuous release of the broad-spectrum antibiotic doxycycline, resulting in a high local concentration of the drug for a period of 30 days for the prevention of SSIs, with additional potential to prevent SSIs caused by antibiotic-resistant bacteria at the surgical site. D-PLEX100 recently demonstrated positive results in the Phase 3 SHIELD II trial, achieving a statistically significant 60% (p=0.0013) relative risk reduction in SSI incidence following abdominal colorectal surgery with large incisions. D-PLEX100 received Breakthrough Therapy designation from the U.S. Food and Drug Administration for the prevention of SSIs in patients undergoing elective colorectal surgery.
공시 • Apr 14PolyPid Ltd Announces New Phase 3 Shield II Data Demonstrating D-Plex100 Sustained Local ReleasePolyPid Ltd. announced that the Company will present new pharmacokinetic data from the Phase 3 SHIELD II trial evaluating D-PLEX100 at the Congress of the European Society of Clinical Microbiology and Infectious Diseases Global 2026, taking place on April 17-21, 2026, in Munich, Germany. The abstract titled “Pharmacokinetics of local extended-release incisional doxycycline in patients undergoing abdominal colorectal surgery from the SHIELD II Phase 3 clinical trial,” was co-authored by Prof. Antonino Spinelli, Director of the Division of Colon and Rectal Surgery and a Professor of Surgery at Humanitas University, in Milan, Italy and PolyPid. Sustained and controlled release profile: Detectable doxycycline concentrations were observed for up to 763 hours (approximately 32 days), with no burst, following local application of D-PLEX100 during surgery. Minimal systemic exposure: Plasma doxycycline concentrations remained below 100 ng/mL, indicating negligible systemic levels relative to oral doxycycline administration where Cmax levels are approximately 16 to 26 times higher (1,613.3 ng/mL for 100 mg and 2,600 ng/mL for 200 mg doses). ESCMID Global 2026 Presentation Details Poster Title: Pharmacokinetics of Local Extended-Release Incisional Doxycycline in Patients undergoing Abdominal Colorectal Surgery from the SHIELD II Phase 3 Clinical Trial Presenter: Eyal Shoshani, VP Clinical Affairs, PolyPid Ltd. Lead Author: Prof. Antonino Spinelli, Humanitas University and IRCCS Humanitas Research Hospital, Milan, Italy Poster Details: #P2740 (Presented at: Poster Hall B3) Session: 05b. Pharmacokinetics/pharmacodynamics of antibacterial drugs & therapeutic drug monitoring Date/Time: Sunday, April 19, 2026 | 12:00 – 13:30 CEST The abstract will be available once the conference concludes. D-PLEX100, PolyPid’s lead product candidate, is designed to provide local prolonged and controlled anti-bacterial activity directly at the surgical site to prevent surgical site infections (“SSIs”). Following the administration of D-PLEX100 into the surgical site, PolyPid’s delivery technology, Kynatrix, pairs with Active Pharmaceutical Ingredients, enabling a prolonged and continuous release of the broad-spectrum antibiotic doxycycline, resulting in a high local concentration of the drug for a period of 30 days for the prevention of SSIs, with additional potential to prevent SSIs caused by antibiotic-resistant bacteria at the surgical site. D-PLEX100 recently demonstrated positive results in the Phase 3 SHIELD II trial, achieving a statistically significant 60% (p=0.0013) relative risk reduction in SSI incidence following abdominal colorectal surgery with large incisions. D-PLEX100 received Breakthrough Therapy designation from the U.S. Food and Drug Administration for the prevention of SSIs in patients undergoing elective colorectal surgery.
새로운 내러티브 • Apr 04Long Regulatory And Commercial Risks Around Lead Therapy Could Eventually Reward Patient HoldersCatalysts About PolyPid PolyPid is a biopharmaceutical company developing locally and systemically delivered, long acting therapies based on its proprietary drug delivery technology, with D PLEX100 for prevention of surgical site infections as its lead program. What are the underlying business or industry changes driving this perspective?
공시 • Mar 31Polypid Ltd Initiates D-Plex100 Nda Submission to FdaPolyPid Ltd. had initiated a New Drug Application submission to the U.S. Food and Drug Administration for D-PLEX100 for the prevention of surgical site infections in patients undergoing colorectal surgery. The NDA is being submitted under the FDA’s Fast Track designation, which allows for rolling review. The submission includes the Chemistry, Manufacturing and Controls and nonclinical sections of the NDA, with additional components, including the clinical section, expected to be submitted in the Second Quarter of 2026. D-PLEX100, PolyPid’s lead product candidate, is designed to provide local prolonged and controlled anti-bacterial activity directly at the surgical site to prevent surgical site infections. Following the administration of D-PLEX100 into the surgical site, PolyPid’s delivery technology, Kynatrix, pairs with Active Pharmaceutical Ingredients, enabling a prolonged and continuous release of the broad-spectrum antibiotic doxycycline, resulting in a high local concentration of the drug for a period of 30 days for the prevention of surgical site infections, with additional potential to prevent surgical site infections caused by antibiotic-resistant bacteria at the surgical site. D-PLEX100 recently demonstrated positive results in the Phase 3 SHIELD II trial, achieving a statistically significant 60% (p=0.0013) relative risk reduction in surgical site infection incidence following abdominal colorectal surgery with large incisions. D-PLEX100 received Breakthrough Therapy Designation from the FDA for the prevention of surgical site infections in patients undergoing elective colorectal surgery.
새로운 내러티브 • Mar 19Regulatory Tailwinds And Extended Release Platform Will Shape A Stronger Long Term OutlookCatalysts About PolyPid PolyPid is a biopharmaceutical company focused on extended release drug delivery products such as D-PLEX100 for prevention of surgical site infections and longer acting metabolic therapies using its Kynatrix technology. What are the underlying business or industry changes driving this perspective?
공시 • Mar 17PolyPid Ltd Announces PDUFA Fee Waiver And NDA Submission Plans For D-PLEX100PolyPid Ltd. announced that the U.S. Food and Drug Administration (FDA) has granted a small business waiver of the Prescription Drug User Fee Act (PDUFA) fee of approximately USD 4.3 million for the New Drug Application (NDA) for D-PLEX100, the Company's lead product candidate for the prevention of surgical site infections (SSIs) in abdominal colorectal surgeries. This meaningful waiver advances PolyPid toward its upcoming NDA submission initiation and enables the Company to focus its resources on commercialization preparations, following the successful Phase 3 SHIELD II trial which demonstrated a 60% (p=0.0013) relative risk reduction in surgical site infections and met its primary and all key secondary endpoints. The Company remains on track to submit the first sections of its rolling NDA by the end of this month, following positive feedback from the FDA during the pre-NDA meeting communication completed in December 2025.
새로운 내러티브 • Mar 05Long Acting Drug Delivery And Metabolic Health Pipeline Will Transform Future ProspectsCatalysts About PolyPid PolyPid is a clinical stage biopharmaceutical company focused on long acting drug delivery products such as D PLEX100 for prevention of surgical site infections and a GLP 1 receptor agonist program for metabolic disease. What are the underlying business or industry changes driving this perspective?
공시 • Jan 28PolyPid Ltd. to Report Q4, 2025 Results on Feb 11, 2026PolyPid Ltd. announced that they will report Q4, 2025 results Pre-Market on Feb 11, 2026
Breakeven Date Change • Dec 31Forecast to breakeven in 2028The 4 analysts covering PolyPid expect the company to break even for the first time. New consensus forecast suggests the company will make a profit of US$5.60m in 2028. Average annual earnings growth of 54% is required to achieve expected profit on schedule.
공시 • Dec 17PolyPid Ltd. Appoints Brooke Story as Chairman of the Board of Directors, Effective December 11, 2025PolyPid Ltd. announced the appointment of Brooke Story as Chairman of the Board of Directors, effective as of December 11, 2025. Ms. Story brings over 25 years of leadership experience in the MedTech industry, having held senior roles at BD (Becton, Dickinson and Company) and Medtronic PLC. As former Worldwide President of BD’s Surgery business, she oversaw global strategy and the P&L for portfolios in hernia repair, tissue repair, and infection prevention. In addition, she has extensive experience leading mergers and acquisitions as well as licensing transactions. She currently serves as BD’s Separation and Integration Lead, managing the Life Sciences divestiture and ongoing global integrations. Alongside her new role with PolyPid, Ms. Story currently serves as a non-executive director on the Board of LivaNova PLC. She previously served on the Board of Sigilon Therapeutics Inc. and as Board observer for Avation Medical Inc. She holds a Bachelor of Science in Engineering from the University of Tennessee and an MBA from the University of Michigan.
공시 • Dec 03PolyPid Ltd. Announces Positive Fda Pre-Nda Meeting Minutes for D-Plex100 Supporting Nda SubmissionPolyPid Ltd. announced that it has received a formal pre-New Drug Application ("NDA") meeting minutes from the U.S. Food and Drug Administration ("FDA") supporting the NDA submission of D-PLEX100, the Company's lead product candidate for the prevention of surgical site infections in abdominal colorectal surgeries. The FDA agreed that the Company's existing clinical data package, including results from the Phase 3 SHIELD II trial, appears adequate to support NDA submission and review. The FDA also agreed to a rolling NDA review, allowing PolyPid to submit the first completed sections in early 2026. Based on the FDA's Pre-NDA meeting written response, the Company concludes that the objectives of the pre-NDA meeting have been accomplished and has determined that the in-person meeting, originally scheduled for December 3, 2025, is no longer necessary. About D-PLEX100: D-PLEX100, PolyPid's lead product candidate, is designed to provide local prolonged and controlled anti-bacterial activity directly at the surgical site to prevent surgical site infections ("SSIs"). Following the administration of D-PLEX100 into the surgical site, the PLEX (Polymer-Lipid Encapsulation matriX) technology pairs with Active Pharmaceutical Ingredients, enabling a prolonged and continuous release of the broad-spectrum antibiotic doxycycline, resulting in a high local concentration of the drug for a period of 30 days for the prevention of SSIs, with additional potential to prevent SSIs caused by antibiotic-resistant bacteria at the surgical site. D-PLEX100 recently demonstrated positive results in the Phase 3 SHield II trial, achieving a statistically significant 58% (p< 0.005) relative risk reduction in SSI incidence following abdominal colorectal surgery with large incisions. D-PLEX100 received Breakthrough Therapy designation from the U.S. food and Drug Administration for the prevention of SSIs in patients undergoing elective colorectal surgery.
New Risk • Nov 14New major risk - Financial positionThe company has less than a year of cash runway based on its current free cash flow trend. Free cash flow: -US$26m This is considered a major risk. With less than a year's worth of cash, the company will need to raise capital or take on debt unless its cash flows improve. This would dilute existing shareholders or increase balance sheet risk. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$26m free cash flow). Shareholders have been substantially diluted in the past year (130% increase in shares outstanding). Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$2.5m net loss in 3 years). Market cap is less than US$100m (US$58.7m market cap).
공시 • Oct 29PolyPid Ltd. to Report Q3, 2025 Results on Nov 12, 2025PolyPid Ltd. announced that they will report Q3, 2025 results at 9:30 AM, US Eastern Standard Time on Nov 12, 2025
분석 기사 • Oct 28Is PolyPid (NASDAQ:PYPD) A Risky Investment?The external fund manager backed by Berkshire Hathaway's Charlie Munger, Li Lu, makes no bones about it when he says...
공시 • Oct 01Polypid Ltd. to Present Its Positive Phase 3 Shield II Topline Results At the 2025 American College of Surgeons Clinical CongressPolyPid Ltd. announced that Dr. Shmuel Sharoni will present the topline results from the Company's successful Phase 3 SHIELD II trial of D-PLEX100 at the upcoming 2025 American College of Surgeons (ACS) Clinical Congress in Chicago, IL. The SHIELD II Phase 3 trial was a prospective, multinational, randomized, double-blind study that successfully met its primary and all key secondary efficacy endpoints. The trial demonstrated that D-PLEX100, when administered alongside standard of care, achieved a 38% reduction (p<0.005) in the combined endpoint of surgical site infections, reinterventions, or mortality compared to standard of care alone. Additionally, the trial showed a 58% reduction (p<0.005) in the rate of surgical site infections in the D-PLEX100 treatment arm.
공시 • Sep 16PolyPid Successfully Completes Israeli Ministry of Health GMP InspectionPolyPid Ltd. announced the successful completion of a routine Good Manufacturing Practice (GMP) inspection by the Israeli Ministry of Health. The inspection, concluded earlier this week, marks the fourth consecutive successful GMP inspection of PolyPid's manufacturing facility. The Israeli Ministry of Health operates under the EU-Israel Agreement on Conformity Assessment and Acceptance (ACAA) framework, whereby European regulatory authorities rely on these inspections for EU GMP compliance certification. This regulatory equivalence confirms that PolyPid's manufacturing facility meets the standards required for commercial production in the European market. The inspection comprehensively evaluated PolyPid's quality systems, manufacturing processes, and facility operations, confirming the Company's readiness to support commercial production of D-PLEX100 following regulatory approvals.
공시 • Aug 12PolyPid Ltd. Announces Management ChangesPolyPid Ltd. announced the appointment of Dr. Nurit Tweezer-Zaks, M.D., M.B.A., as Chief Medical Officer, effective as of August 18, 2025. Dr. Tweezer-Zaks, who has served on PolyPid's Board of Directors (the “Board”) since November 2023, will step down from the Board, effective as of August 17, 2025 as she assumes this new executive role. Dr. Tweezer-Zaks brings to PolyPid extensive executive, medical, and research and development expertise. Prior to joining PolyPid, she served as Chief Executive Officer of MediCane Health Inc., a fully integrated global medical cannabis company. Previously, Dr. Tweezer-Zaks held senior positions at aMOON Venture Capital Fund, a leading Israel-based life sciences-focused venture capital investor, where she most recently served as Chief Medical Officer. She also held increasingly senior positions at Sanofi, where she focused on external innovation and partnering and on life cycle management of portfolio products as Global Established Products Medical Lead. Dr. Tweezer-Zaks began her career as a practicing internal medicine and rheumatology physician at Sheba Medical Center in Israel for nearly 15 years. Dr. Tweezer-Zaks holds M.D. and B.S. degrees from Ben-Gurion University School of Medicine in Beer Sheva, Israel, and earned an M.B.A. from the Kellogg-Recanati International Executive MBA Program, a global partnership program between Northwestern University'sKellogg School of Management in Evanston, IL, and Tel Aviv University'sRecanati Graduate School of Business Administration in Israel.
공시 • Jul 30PolyPid Ltd. to Report Q2, 2025 Results on Aug 13, 2025PolyPid Ltd. announced that they will report Q2, 2025 results Pre-Market on Aug 13, 2025
공시 • Jul 15PolyPid Ltd. Unveils A Long-Acting GLP-1 Receptor Agonists Delivery Platform Targeting the Diabetes and Weight Loss MarketPolyPid Ltd. unveiled its long-acting GLP-1 receptor agonists (glucagon-like peptide-1 RA) delivery platform which aims to subcutaneously release GLP-1 RA for approximately 60 days, significantly longer than current weekly injection regimens. The platform releases GLP-1 in a linear way, overcoming the burst release seen with the current weekly delivered molecules. This discovery has the potential to significantly expand PolyPid's offering to a market which is projected to reach $100 billion by 2030. PolyPid's proprietary technology is a sophisticated drug delivery system consisting of a polymer-lipid based matrix that creates a protected drug reservoir. This unique matrix architecture enables controlled and continuous drug delivery in the body over a prolonged time (we weeks to months) in a single application. The technology has been clinically validated in over 1,000 patients including in two Phase 3 trials with no major safety concern.
공시 • Jun 10PolyPid Announces Positive Topline Results from Phase 3 SHIELD II Trial: D-PLEX100 Demonstrated Significant Reduction in Surgical Site Infections and Successfully Met Primary and All Key Secondary EndpointsPolyPid Ltd. announced positive topline results from its pivotal SHIELD II Phase 3 trial of D-PLEX100 for the prevention of SSIs in patients undergoing abdominal colorectal surgery with large incisions, which has received Fast Track designation from the FDA. Key findings from SHIELD II study include: The primary efficacy endpoint of the study was successfully met, with a significantly lower proportion of primary endpoint events among patients who received D-PLEX100 plus SoC (n=405; 10. 9%), compared to SoC alone (n=393; 18. 1%), representing a 38% reduction (p<0. 005). The primary endpoint is the combination of deep and superficial SSIs, all-cause mortality and surgical reinterventions at the same incision of the original index surgery. SHIELD II included three key secondary endpoints: The first key secondary endpoint was met, with a 58% reduction in deep and superficial SSI rates among patients who received D-PLEX100 plus SoC (3. 8%) compared to those who received SoC alone (9.5%) (p<0. 005). The second key secondary endpoint showed statistical significance in favor of D-PLEX100 plus SoC over SoC alone (p<0. 005). This efficacy endpoint combined SSI, mortality and reintervention as evaluated in the primary endpoint. This endpoint was assessed in the overall study population of 975 patients with an incision =7 cm, including laparoscopic surgery patients enrolled prior to the 2023 trial protocol change. The third key secondary endpoint was met with a 62% reduction of patients with an ASEPSIS score >20 in D-PLEX100 plus SoC arm compared to SoC alone arm (p<0. 05). The ASEPSIS score is a clinical tool used to objectively assess surgical wound infections. There were no safety concerns raised by the independent Data Safety Monitoring Board in SHIELD II.
Breakeven Date Change • Jun 06No longer forecast to breakevenThe 4 analysts covering PolyPid no longer expect the company to break even during the foreseeable future. The company was expected to make a profit of US$55.6m in 2027. New consensus forecast suggests the company will make a loss of US$20.1m in 2027.
공시 • May 23PolyPid Ltd., Annual General Meeting, Jun 25, 2025PolyPid Ltd., Annual General Meeting, Jun 25, 2025. Location: 18 hasivim street, petach tikva 4959376, Israel
공시 • Apr 29PolyPid Ltd. to Report Q1, 2025 Results on May 14, 2025PolyPid Ltd. announced that they will report Q1, 2025 results at 9:30 AM, US Eastern Standard Time on May 14, 2025
공시 • Mar 11PolyPid Ltd. Announces Successful Completion of Enrollment in Phase 3 SHield II Trial of D-PLEX100 for the Prevention of Abdominal Colorectal Surgical Site InfectionsPolyPid Ltd. announced the successful completion of enrollment in the SHIELD II Phase 3 trial for D-PLEX100 for the prevention of surgical site infections in patients undergoing abdominal colorectal surgery. This milestone follows recommendation by the independent Data Safety Monitoring Board ("DSMB"), which, after analyzing unblinded efficacy data from the first 430 enrolled patients in the trial, recommended concluding the study upon enrollment of 800 patients, the lowest sample size reassessment stop after the minimum planned number of patients. The Company anticipates reporting top-line results by the end of the second quarter of 2025. If the Phase 3 data are positive, PolyPid expects to submit a New Drug Application ("NDA") to the U.S. Food and Drug Administration ("FDA"), leveraging the FDA's Fast Track and Breakthrough Therapy designations.
공시 • Jan 29PolyPid Ltd. to Report Q4, 2024 Results on Feb 12, 2025PolyPid Ltd. announced that they will report Q4, 2024 results Pre-Market on Feb 12, 2025
공시 • Dec 24PolyPid Ltd. Announces Positive Recommendation by DSMB to Continue Enrollment of Phase 3 SHield II Trial of D-PLEX100 to 800 Patients with a Concurrent Private Placement of Up to $41 MillionPolyPid Ltd. announced that following the independent Data Safety Monitoring Board's review of unblinded efficacy data from the first 430 enrolled patients in the SHIELD II Phase 3 trial for D-PLEX100 for the prevention of surgical site infections in patients undergoing abdominal colorectal surgery with large incisions, the DSMB's recommendation was to conclude the study upon enrollment of 800 patients, which is the lowest sample size reassessment stop after the minimum planned number of 624 patients. At this interim analysis, the DSMB also had the option to recommend stopping SHIELD II due to futility or overwhelming efficacy or to reassess the trial's sample size to a maximum of 1,100 patients. exercise of the warrants in full would result in an additional $27.0 million in gross proceeds to the Company. The PIPE is expected to close on December 26, 2024, subject to the satisfaction of customary closing conditions. The Company intends to use the net proceeds from the sale of the securities for its ongoing SHIELD II Phase 3 clinical trial, working capital and general corporate purposes. The gross proceeds from the financing extend PolyPid's cash runway into the third quarter of 2025, beyond expected top-line results from SHIELD II. Proceeds of all warrants issued in this transaction, if exercised, would provide the Company with capital beyond NDA approval. Citizens JMP is acting as exclusive placement agent in the offering.
공시 • Nov 30PolyPid Announces Receipt of Nasdaq Notification of Minimum Stockholders’ Equity Non-CompliancePolyPid Ltd. announced that it has received a written notification (the "Notification Letter") from the Listing Qualifications staff of The Nasdaq Stock Market LLC (“Nasdaq”) notifying the Company that it is no longer in compliance with the minimum stockholders' equity requirement for continued listing on the Nasdaq Capital Market, listing Rule 5550(b)(1), due to its failure to maintain a minimum of $2,500,000 in stockholders' equity. In the Company's Form 6-K dated November 13, 2024, the Company reported stockholders' equity of approximately $2,158,000 as of September 30, 2024. In accordance with Nasdaq rules, the Company has 45 calendar days, or until January 9, 2025, to submit a plan to regain compliance. If the plan is accepted, Nasdaq can grant an extension of up to 180 calendar days from the date of the letter to evidence compliance. The Notification Letter has no immediate effect on the Company’s listing on the Nasdaq Capital Market, and during the grace period, as may be extended, the Company’s ordinary shares will continue to trade on Nasdaq under the symbol “PYPD”.Outcome of the unblinded interim analysis in Company’s ongoing SHIELD II Phase 3 trial evaluating D-PLEX100 for the prevention of abdominal colorectal surgical site infections is expected in December 2024. Under the terms of the Company’s private placement financing that closed in January 2024 (“January PIPE”), the Company has the potential to secure an additional $18.5 million if the unblinded interim analysis results in the stopping of the trial due to positive efficacy and all warrants are exercised. In addition, under the terms of the private placement financing that closed in August 2024 (“August PIPE”), the Company has the potential to secure an additional $6.1 million if the unblinded interim analysis results in either the stopping of the trial due to positive efficacy, or continuation to planned patient recruitment (up to 630 subjects) and all warrants are exercised. The Company expects that it will be able to demonstrate compliance with the Nasdaq stockholders’ equity requirement if warrants issued under the January PIPE and the August PIPE are exercised.
공시 • Nov 10PolyPid Ltd. has filed a Follow-on Equity Offering in the amount of $8.25 million.PolyPid Ltd. has filed a Follow-on Equity Offering in the amount of $8.25 million. Security Name: Ordinary Shares Security Type: Common Stock Transaction Features: At the Market Offering
공시 • Oct 30PolyPid Ltd. to Report Q3, 2024 Results on Nov 13, 2024PolyPid Ltd. announced that they will report Q3, 2024 results Pre-Market on Nov 13, 2024
공시 • Jul 31PolyPid Ltd. to Report Q2, 2024 Results on Aug 14, 2024PolyPid Ltd. announced that they will report Q2, 2024 results Pre-Market on Aug 14, 2024
공시 • Jun 18PolyPid Ltd. Hosts Kol Call to Discuss Significant Unmet Medical Need in Surgical Site Infections Prevention and Provides Update on Its Ongoing Shield II Phase 3 TrialPolyPid Ltd. hosted a virtual Key Opinion Leader event discussing the significant unmet medical need in the prevention of surgical site infections (SSIs). The Company also provided an update on its ongoing SHIELD II Phase 3 trial for D-PLEX100. Charles E. Edmiston, Ph.D. (Emeritus Professor of Surgery, Division of Vascular Surgery, Medical College of Wisconsin), discussed several key topics surrounding SSIs. Key takeaways include: The return to higher pre-COVID SSI rates due to the increase in the number of elective surgeries conducted and the surgical environment normalizing to levels found prior to 2020. SSIs are under-reported, and up to 30-35% of colorectal infections are missed due to sub-optimal surveillance strategies. Procedural and patient-related risk factors such as smoking, alcohol abuse, type 2 diabetes and a high BMI have a significant negative impact on the risk of developing a SSI, and this increase in risk is compounded when patients have multiple risk factors. Long term cost to commercial payers of a single colorectal SSI event over a period of 24 months can range from $44,000 (superficial SSI) to $64,000 (deep SSI), with the cost for Medicare ranging from $20,000 to $45,000, respectively. Surgical care bundles in patients undergoing colorectal surgery significantly reduce the risk of SSIs. The 30-day high concentration release of antibiotics achieved with D-PLEX100 has the potential to add additional benefit to infection prevention bundles. PolyPid also provided an update on the enrollment of its ongoing Phase 3 SHIELD II trial of its lead product candidate, D-PLEX100. The SHIELD II clinical study includes patients undergoing abdominal colorectal surgery with large incisions and has now enrolled approximately 250 patients of a planned total of approximately 600 subjects. Approximately 50 centers are currently open and recruiting patients. Top-line results are expected in the first quarter of 2025. The Company intends to conduct an unblinded interim analysis once a total of approximately 400 patients complete their 30-day follow-up, which is anticipated to occur in the fourth quarter of 2024.
공시 • May 31PolyPid Ltd., Annual General Meeting, Jul 02, 2024PolyPid Ltd., Annual General Meeting, Jul 02, 2024. Location: 18 hasivim street, 4959376, petach tikva Israel
공시 • Apr 30PolyPid Ltd. Announces Enrollment of 200th Patient in Ongoing SHIELD II Phase 3 Trial Evaluating D-PLEX100 for the Prevention of Abdominal Colorectal Surgical Site InfectionsPolyPid Ltd. announced that it has enrolled the 200th patient in its ongoing SHIELD II Phase 3 trial for D-PLEX100 for the prevention of surgical site infections in patients undergoing abdominal colorectal surgery with large incisions. The study is now approximately one-third enrolled and is anticipated to continue enrollment at a pace of 1.5 patients per center per month. There are currently approximately 40 centers open and the Company expects to add approximately 20 more centers over the next couple of months. An unblinded interim analysis is anticipated to be conducted in mid-2024, once a total of approximately 400 patients complete their 30-day follow-up.
공시 • Apr 26PolyPid Ltd. to Report Q1, 2024 Results on May 08, 2024PolyPid Ltd. announced that they will report Q1, 2024 results Pre-Market on May 08, 2024
공시 • Feb 12PolyPid Ltd. Announces Enrollment of the 100th Patient in the Ongoing Shield II Phase 3 TrialPolyPid Ltd. announced that it has enrolled and randomized the 100th patient in its ongoing SHIELD II Phase 3 trial for D-PLEX100 for the prevention of surgical site infections in patients undergoing abdominal colorectal surgery with large incisions. There are currently approximately 40 centers open. The Company intends to conduct an unblinded interim analysis once a total of approximately 400 patients complete their 30-day follow-up, which is expected to occur in mid-2024.
공시 • Feb 01PolyPid Ltd. to Report Q4, 2023 Results on Feb 14, 2024PolyPid Ltd. announced that they will report Q4, 2023 results Pre-Market on Feb 14, 2024
공시 • Jan 22PolyPid Ltd. announced that it has received $35.01012 million in funding from Dafna Capital Management, LLC, Rosalind Advisors, Inc.On January 22, 2024, PolyPid Ltd., closed the transaction. The company has raised $35,010,120 from 20 investors pursuant to Regulation D.
공시 • Jan 05PolyPid Ltd. announced that it expects to receive $16.216011 million in funding from Dafna Capital Management, LLC, Rosalind Advisors, Inc. and other investorsPolyPid Ltd. announced that it has entered into a securities purchase agreement for a private placement financing to issue 3,371,312 of the Company’s ordinary shares at an issue price of $4.81 per share for the gross proceeds of $16,216,010.72 on January 4, 2023. The transaction will include participation from new and existing investors, including participation from new U.S. life sciences-focused investors, DAFNA Capital Management and Rosalind Advisors. The investors will also receive warrants to purchase up to 3,371,312 Ordinary Shares at an exercise price of $5.50 per share. The warrants expire upon the earlier of two years from the date of issuance Exercise of the warrants in full would result in an additional $18,500,0000 in gross proceeds to the Company.
공시 • Nov 08Polypid Announces the Addition of Dr. Nurit Tweezer-Zaks to Its Board of DirectorsPolyPid Ltd. announced the appointment of Nurit Tweezer-Zaks, M.D., M.B.A, to its Board of Directors, effective November 6, 2023, following the retirement of Anat Tsour Segal. Dr. Tweezer-Zaks is a biopharmaceutical industry veteran with extensive executive business development, clinical, and R&D expertise. She is an experienced sector investor and was a practicing physician for nearly 15 years. Dr. Tweezer-Zaks currently serves as Chief Executive Officer of MediCane Health, a fully-integrated global medical cannabis company. Previously, Dr. Tweezer-Zaks served in increasingly senior positions at aMOON, a leading Israel-based life sciences-focused venture capital investor. In her most recent role as Chief Medical Officer at aMOON, she managed the internal and external interfaces across the fund between investors, portfolio companies, and investment teams, and provided professional input to the investment committee. Prior to this, Dr. Tweezer-Zaks held increasingly senior positions at Sanofi. In her most recent role at Sanofi, she served as Global Established Products Medical Lead – Strategic Decision for Portfolio Enhancement. In this role Dr. Tweezer-Zaks focused on life cycle management of portfolio products. She began her career as a practicing internal medicine physician at Sheba Medical Center in Israel. Dr. Tweezer-Zaks has authored numerous scientific publications. She holds M.D. and B.S. degrees from Ben-Gurion University School of Medicine in Beer Sheva, Israel, and earned an M.B.A. from the Kellogg-Recanati International Executive MBA Program, a global partnership program between Northwestern University’s Kellogg School of Management in Evanston, IL, and Tel Aviv University’s Recanati Graduate School of Business Administration in Israel.
공시 • Nov 02PolyPid Ltd. to Report Q3, 2023 Results on Nov 08, 2023PolyPid Ltd. announced that they will report Q3, 2023 results Pre-Market on Nov 08, 2023
공시 • Oct 12PolyPid Regains Compliance with Nasdaq Minimum Closing Bid Price RulePolyPid Ltd. announced that it has received a written notice from The Nasdaq Stock Market LLC ("Nasdaq") that the Company has regained compliance with the minimum bid price requirement for continued listing set forth in Nasdaq Listing Rule 5550(a)(2), which requires listed securities, including the Company's ordinary shares, to maintain a minimum bid price of $1.00 per share. The Nasdaq staff made this determination of compliance after the closing bid price of the Company's ordinary shares was at $1.00 per share or greater for the 11 consecutive business days prior to the date of the notice. Accordingly, the Company has regained compliance with Nasdaq Listing Rule 5550(a)(2), and Nasdaq considers the prior bid price deficiency matter now closed.
공시 • Sep 21PolyPid Announces Reverse Share Split to Regain Compliance with Nasdaq’s $1.00 Minimum Bid Price RequirementPolyPid Ltd. (“PolyPid” or the “Company”) announced a reverse share split (the “Reverse Split”) of the Company’s issued and outstanding ordinary shares, no par value (“Ordinary Shares”), at the ratio of 1-for-30, such that each thirty Ordinary Shares, shall be consolidated into one Ordinary Share. The Company obtained shareholders’ approval for the Reverse Split at a ratio of between 1:10 and 1:30 at an extraordinary general meeting of shareholders, which took place on September 18, 2023. The Company’s board of directors then approved the Reverse Split ratio of 1-for-30 on September 18, 2023. The first date when the Company’s Ordinary Shares will begin trading on the Nasdaq Capital Market (“Nasdaq”) on a post- reverse split basis is expected to be September 21, 2023. The Company’s Ordinary Shares will continue to trade on the Nasdaq under the symbol “PYPD” and the Company expects that the reverse share split will allow the Company to regain compliance with Nasdaq’s $1.00 minimum bid price requirement.
공시 • Sep 20PolyPid Ltd. Announces Successful Completion of Manufacturing Process Validation for D-PLEX100PolyPid Ltd. announced the successful completion of the production of three process validation batches of D-PLEX100 which have started stability program. This successful production process validation completes a substantial requirement toward the Company’s planned submission of D-PLEX100 New Drug Application (NDA) and Marketing Authorization Application (MAA) regulatory filings. PolyPid’s ongoing Phase 3 SHIELD II trial of D-PLEX100 for the prevention of surgical site infections (SSIs) is currently recruiting patients undergoing open abdominal colorectal surgery with large incisions. Top-line results are expected in mid-2024. D-PLEX100, PolyPid’s lead product candidate, is designed to provide local prolonged and controlled anti-bacterial activity directly at the surgical site to prevent SSIs. Following the administration of D-PLEX100 into the surgical site, the PLEX (Polymer-Lipid Encapsulation matriX) technology pairs with Active Pharmaceutical Ingredients, enabling a prolonged and continuous release of the broad-spectrum antibiotic doxycycline, resulting in a high local concentration of the drug for a period of 30 days for the prevention of SSIs, with additional potential to prevent SSIs caused by antibiotic-resistant bacteria at the surgical site. D-PLEX100 received Breakthrough Therapy Designation from the U.S. Food and Drug Administration for the prevention of SSIs in patients undergoing elective colorectal surgery. D-PLEX100 also received three Qualified Infectious Disease Product (QIDP) designations, and three Fast Track designations for the prevention of SSIs in patients undergoing elective colorectal surgery, post-abdominal surgery incisional infection and for the prevention of sternal wound infection post-cardiac surgery.
공시 • Jul 28PolyPid Ltd. to Report Q2, 2023 Results on Aug 09, 2023PolyPid Ltd. announced that they will report Q2, 2023 results Pre-Market on Aug 09, 2023
공시 • Jun 30Polypid Ltd. Announces New Publication Highlighting Potent Antibacterial Activity of D-Plex Against Susceptible and Resistant Bacteria for the Prevention of Surgical Site InfectionsPolyPid Ltd. announced a new publication highlighting the potent antibacterial activity of D-PLEX(100) and its potential as an effective prophylactic drug against the most prevalent bacteria causing surgical site infections (SSIs), including resistant strains. The paper, entitled, "Potent antibacterial activity in surgical wounds with local administration of D-PLEX(100) was recently published in the European Journal of Pharmaceutical Sciences and can be found here. The efficacy and safety of D-PLEX(50) for the prevention of abdominal colorectal SSIs are currently being further evaluated in the SHIELD II Phase 3 clinical trial. Top-line results are expected in mid-2024. Following the administration of D-PLEX (Polymer-Lipid Encapsulation matriX) technology pairs with Active Pharmaceutical Ingredients, enabling a prolonged and continuous release of the broad-spectrum antibiotic doxycycline, resulting in a high local concentration of the drug for a period of 30 days for the prevention of SSIs, with additional potential to prevent SSIs caused by antibiotic-resistant bacteria at the surgical site. D-PLEX(100") received Breakthrough Therapy Designation from the U.S. FDA for the prevention of SSIs in patients undergoing elective colorectal surgery. D-PLEX(100") also received three Qualified Infectious Disease Product (QIDP) designations, and three Fast Trackdesignations for the prevention of SSIsin patients undergoing elective coloreCTal surgery, post-abdominal surgery incisional infection and for the prevention of sternal wound infection post-cardiac surgery. Through locally administered, controlled,release therapeutics, PolyPid's proprietary PLEX (Polymer-LIPid Encapsulation matri X) technology pairs with Active Pharmaceutical ingredients (APIs), enabling precise delivery of drugs at optimal release rates over durations ranging from several days to months. PolyPid's lead product candidate D-PLEX(100). is in Phase 3 clinical trial for the prevention of abdominal colores colorectal SSIs are currently being further evaluated in the SHIELD II Phase 3 clinical trial. Top-line results are expected in mid-2024. About D-PLEX(100) D-PLEX(100,) PolyPid's lead product candidate, is designed to provide local prolonged and controlled anti-bacterial activity directly at the surgical site to prevent SSIs. Following the administration of D-PLEX(100) into the surgical site, the PLEX (Polymer-Lipid Encapsulation matriX) technology pairs with Active Pharmaceutical Ingredients, enabling a prolonged and continuous release of the broad-spectrum antibiotic doxycycline, resulting in a high local concentration of the drug for a period of 30 days for the prevention of SSIs, with additional potential to prevent SSIs caused by antibiotic-resistant bacteria at the surgical site. D-PLEX(100) received Breakthrough Therapy Designation from the U.S. FDA for the prevention of SSIs in patients undergoing elective colorectal surgery. D-PLEX(100) also received three Qualified Infectious Disease Product (QIDP) designations, and three Fast Track designations for the prevention of SSIs in patients undergoing elective colorectal surgery, post-abdominal surgery incisional infection and for the prevention of sternal wound infection post-cardiac surgery.
공시 • Jun 23PolyPid Ltd. Announces Recruitment of First Patient in Revised Shield Ii Phase 3 Trial Evaluating D-Plex100 for Prevention of Abdominal Colorectal Surgical Site InfectionsPolyPid Ltd. announced that the first patient has been recruited and is scheduled for surgery in its revised SHIELD II Phase 3 trial evaluating D-PLEX100 for the prevention of abdominal colorectal surgical site infections (SSIs). The U.S. Food and Drug Administration (FDA) recently accepted the Company's revised protocol for SHIELD II, which is recruiting patients undergoing colorectal resection surgery with large incisions (> 20 cm). SHIELD II will enroll an estimated 550 additional patients beyond the 40 patients already recruited into the trial. Total recruitment time into the trial is anticipated to be approximately 12 months and top-line results are expected in mid-2024. PolyPid also intends to conduct an unblinded interim analysis once a total of approximately 400 patients complete their 30-day follow-up.
공시 • Jun 06PolyPid Announces 180-Day Extension to Regain Compliance with Nasdaq Minimum Bid Requirement and Transfer of its Listing to the Nasdaq Capital MarketPolyPid Ltd. announced it has received an extension of the period to regain compliance with The Nasdaq Stock Market LLC’s ("Nasdaq") minimum bid price rule and approval from Nasdaq to transfer the listing of the ordinary shares of the Company (the “Ordinary Shares”) from The Nasdaq Global Market to The Nasdaq Capital Market. The transfer will become effective at the opening of business on June 6, 2023. As previously disclosed, on December 6, 2022, the Company received a letter from Nasdaq indicating that the Company was not in compliance with Nasdaq Listing Rule 5450(a)(1), as the closing bid price of its Ordinary Shares had been below $1.00 per Ordinary Share for the previous 30 consecutive business days. The Company was given a period of 180 calendar days, or until June 5, 2023, to regain compliance with the minimum bid price requirement. In order to be provided with a second 180-day compliance period, the Company submitted an application to transfer the listing of its Ordinary Shares from the Nasdaq Global Market to the Nasdaq Capital Market. The Company’s Ordinary Shares continue to trade under the symbol “PYPD” and trading of its Ordinary Shares will not be affected by this transfer. The Nasdaq Capital Market is a continuous trading market that operates in substantially the same manner as The Nasdaq Global Market. The approval of the second compliance period and the transfer to the Nasdaq Capital Market was based upon the Company meeting the applicable market value of publicly held shares requirement for continued listing and all other applicable requirements for initial listing on the Capital Market, except for the bid price requirement, the Company’s written notice of its intention to cure the deficiency by effecting a reverse stock split, if necessary, and additional supporting information provided in its application. In connection with the transfer to the Nasdaq Capital Market, Nasdaq granted the Company an additional 180-day period (or until December 4, 2023) to regain compliance with the requirement set in Nasdaq Listing Rule 5450(a)(1) that the bid price of the Company’s Ordinary Shares meet or exceed $1.00 per Ordinary Share for at least ten consecutive business days. If at any time during this additional time period the closing bid price of the Company’s security is at least $1.00 per share for a minimum of 10 consecutive business days, Nasdaq will provide written confirmation of compliance and this matter will be closed.
공시 • May 23PolyPid Ltd Announces FDA Agreement on the Design of SHIELD II Phase 3 Trial Evaluating D-PLEX100 for Prevention of Abdominal Colorectal Surgical Site InfectionsPolyPid Ltd. announced that the U.S. Food and Drug Administration (FDA) agreed to Company’s SHIELD II Phase 3 trial design evaluating D-PLEX100 for the prevention of abdominal colorectal surgical site infections (SSIs). The revised SHIELD II trial will recruit patients undergoing colorectal resection surgery with large incisions (> 20 cm). Recruitment into the trial will resume imminently with the enrollment of an estimated 550 additional patients beyond the 40 patients already recruited into SHIELD II. Total recruitment time into the study is anticipated to be approximately 12 months and top-line results are expected in mid-2024. PolyPid also intends to conduct an unblinded interim analysis once a total of approximately 400 patients complete their 30-day follow-up. SHIELD II (Surgical site Hospital acquired Infection prEvention with Local D-PLEX) is a prospective, multinational, randomized, double blind Phase 3 trial designed to assess the efficacy and safety of D-PLEX100 administered concomitantly with standard of care (SoC), which includes prophylactic systemic antibiotics, compared to SoC alone arm, in the prevention of post abdominal-surgery incisional infection in patients undergoing surgeries with incisions greater than 20 cm. The primary endpoint of the trial is measured by the proportion of subjects with either an SSI event as determined by a blinded and independent adjudication committee, reintervention, or mortality for any reason within 30 days post-surgery. Patient safety will be monitored for an additional 30 days. The trial will enroll patients in centers in the United States, Europe and Israel.
공시 • May 11+ 1 more updatePolyPid Ltd. Announces Board ChangesPolyPid Ltd. announced that appointment of Yossi BenAmram, former SVP and President of Merck & Co.’s Europe, Russia, Africa, and Middle East region, as an independent Director on the Company’s Board, replacing Mr. Chaim Hurvitz, a member of the Board since 2016, effective May 8, 2023.
공시 • Feb 01PolyPid Ltd. to Report Q4, 2022 Results on Feb 08, 2023PolyPid Ltd. announced that they will report Q4, 2022 results Pre-Market on Feb 08, 2023
공시 • Jan 25PolyPid Provides Positive Regulatory Update for D-PLEX100 for the Prevention of Surgical Site Infections in Abdominal Colorectal SurgeryPolyPid Ltd. provided a positive regulatory update for D-PLEX100 for the prevention of abdominal colorectal surgical site infections (SSIs). Following a recent type D meeting communication with the U.S. Food and Drug Administration (FDA) on the SHIELD I Phase 3 data, the Company now has clarity regarding the regulatory pathway toward a potential New Drug Application (NDA) submission. PolyPid provided to the FDA currently available data from the SHIELD I study evaluating D-PLEX100 for the prevention of abdominal colorectal SSIs. Based on the data, particularly the 54% reduction observed in the primary endpoint in complex surgeries in a pre-specified subgroup analysis of patients with large incisions (>20 cm) (p=0.0032, n=423) compared to standard of care, the FDA acknowledged that the SHIELD I results may provide supportive evidence on this population and recommended that the Company conduct an additional study to support a potential NDA submission. The FDA stated that the ongoing SHIELD II study, which to date has enrolled over 200 patients, could potentially serve as such a study. PolyPid is now working expeditiously to finalize the design of the revised SHIELD II trial and expects to resume patient recruitment next quarter.
공시 • Jan 04Polypid Ltd. Announces Publication in the American Journal of Surgery of Phase 2 Clinical Trial Post-Hoc Analysis for D-PLEX in the Prevention of Surgical Site Infections in Abdominal SurgeryPolyPid Ltd. announced the peer-reviewed publication of a post-hoc analysis from the previously-completed Phase 2 study of D-PLEX100 for the prevention of surgical site infections (SSIs) in abdominal surgery. The paper, entitled, “Reduction in Surgical Site Infections by Localized Administration with D-PLEX100 in Patients with Multiple Risk Factors Undergoing Colorectal Surgery. The Phase 2 trial was a prospective, multicenter, randomized, controlled, single-blind, two arm study and was designed to assess the efficacy and the safety of D-PLEX100 in addition to standard of care (SoC) in preventing superficial and deep SSIs in patients undergoing elective colorectal surgery. This post-hoc analysis was intended to evaluate the effect of D-PLEX100 on SSI incidence in patients with multiple preoperative risk factors. Thirty-day SSI rates were examined in patients in the Intention-to-treat (ITT) population and in those with two or more patient related risk factors. Individual risk factor categories included diagnoses of diabetes, chronic obstructive pulmonary disease (COPD) or a history of smoking, obesity/overweight as defined as a body mass index (BMI) of 25 or more, hypertension, and peripheral vascular disease. The distribution of the assessed risk factors between the D-PLEX100 plus SoC and SoC cohorts was approximately even. Two hundred and one patients were evaluated in the ITT population, 101 in the intervention arm and 100 in the control arm. The study showed a 53% statistically significant relative risk reduction of the SSI rate (superficial and deep) within 30 days post-index surgery in the D-PLEX100 cohort (N=10/101 [9.9%]) compared to SoC (N=21/100 [21%]; p = 0.033). In patients with two or more risk factors, the SSI rate in the D-PLEX100 plus SOC cohort was 15.8% (6/38) compared to 37.5% (15/40) in the SOC alone cohort, demonstrating a statistically significant relative risk reduction of 58% (p = 0.042).
공시 • Dec 13PolyPid Ltd. Announces Scheduling of Type D Meeting with U.S. FDA to Discuss SHIELD I Phase 3 Results and Regulatory Pathway for D-PLEX100 for the Prevention of Surgical Site Infections in Abdominal Colorectal SurgeryPolyPid Ltd. announced that a Type D meeting has been scheduled for January 2023 with the U.S. Food and Drug Administration (FDA) to discuss the results of SHIELD I Phase 3 study and regulatory requirements to support the indication of D-PLEX100 for the prevention of abdominal colorectal surgical site infections (SSIs). In advance of the meeting, PolyPid recently provided the FDA with currently available data from the completed SHIELD I study. The FDA established Type D meetings to provide an opportunity for companies to address more focused issues on a shorter timeline than other meeting types normally allow. A Type D meeting is focused on a narrow set of issues and is limited to no more than two focused topics. The FDA aims to conduct Type D meetings with companies within 50 calendar days after receipt of the meeting request.
공시 • Dec 12PolyPid Announces Receipt of Nasdaq Minimum Bid Price NotificationPolyPid Ltd. announced that it has received a written notice (the "Notice") from Nasdaq Stock Market LLC ("Nasdaq") indicating that the Company is not in compliance with the minimum bid price requirement for continued listing set forth in Nasdaq Listing Rule 5550(a)(2), which requires listed securities to maintain a minimum bid price of $1.00 per share. Under Nasdaq Listing Rule 5810(c)(3)(A), the Company has been granted a period of 180 calendar days to regain compliance with the minimum bid price requirement. The Notice has no immediate effect on the Company's Nasdaq listing or the trading of its ordinary shares, and during the grace period, as may be extended, the Company's ordinary shares will continue to trade on Nasdaq. According to the Notice, the Company has until June 5, 2023 to regain compliance with the minimum bid price requirement. The Company can regain compliance, if at any time during this 180-day period, the closing bid price of its ordinary shares is at least $1.00 for a minimum of ten consecutive business days, in which case the Company will be provided with written confirmation of compliance and this matter will be closed. In the event that the Company does not regain compliance after the initial 180-day period, the Company may then be eligible for an additional 180-day compliance period if it meets the continued listing requirement for market value of publicly held shares and all other initial listing standards for The Nasdaq Capital Market, with the exception of the minimum bid price requirement. In this case, the Company will need to provide written notice of its intention to cure the deficiency during the second compliance period. If the Company cannot demonstrate compliance by the allotted compliance period(s), Nasdaq's staff will notify the Company that its ordinary shares are subject to delisting.
Price Target Changed • Nov 16Price target decreased to US$3.38Down from US$21.50, the current price target is an average from 4 analysts. New target price is 321% above last closing price of US$0.80. Stock is down 89% over the past year. The company is forecast to post a net loss per share of US$1.94 next year compared to a net loss per share of US$2.28 last year.
공시 • Oct 27PolyPid Ltd. to Report Q3, 2022 Results on Nov 09, 2022PolyPid Ltd. announced that they will report Q3, 2022 results at 9:30 AM, US Eastern Standard Time on Nov 09, 2022
Seeking Alpha • Oct 20PolyPid set to cut 20% jobsPolyPid (NASDAQ:PYPD) announced on Thursday a cost reduction plan, including a 20% job cut across all departments as it expects the actions to extend tits cash runway into Q3 2023. The company expects to discuss regulatory pathway for D-PLEX100 for prevention of surgical site infections in abdominal surgery with U.S. and EU regulatory authorities in Q1 2023. As of February 28, the company had 78 full-time employees.
공시 • Sep 29Polypid Ltd. Announces Eligibility for European Medicines Agency Centralized Procedure for D-Plex100 for the Prevention of Surgical Site Infections in Abdominal SurgeryPolyPid Ltd. announced that it has received confirmation from the European Medicines Agency (EMA) that D-PLEX100 is eligible for submission of a Marketing Authorization Application (MAA) in the European Union (EU) under the Agency’s centralized procedure. The centralized procedure allows the submission of a single marketing application to the EMA that, if approved, enables the product to be marketed in all EU member states as well as in Iceland, Liechtenstein and Norway. The centralized process eligibility is granted to D-PLEX100 under the Therapeutic Innovation criteria which underscores that D-PLEX100 provides a new alternative to patients in preventing post abdominal surgical site infections (SSIs).
Seeking Alpha • Sep 28PolyPid's surgical site infections treatment eligible for marketing nod submission in EUPolyPid (NASDAQ:PYPD) on Wednesday said it had got confirmation from Europe's drug regulator that its D-PLEX100 product candidate for the treatment of surgical site infections was eligible to be submitted for a marketing authorization. The company said the product candidate was eligible for the European Medicines Agency's (EMA) centralized procedure under the therapeutic innovation criteria. "The centralized procedure allows the submission of a single marketing application to the EMA that, if approved, enables the product to be marketed in all EU member states as well as in Iceland, Liechtenstein and Norway," PYPD said in a statement. The company is currently evaluating its recently concluded phase 3 trial which evaluated D-PLEX100 for the prevention of surgical site infections in abdominal surgery. PYPD said it intends to discuss the data from the late-stage trial and potential next steps with U.S. and EU regulators in Q1 2023. PolyPid (PYPD) stock +1.2% to $1.10 in morning trading.
공시 • Sep 20PolyPid Announces Peer-Reviewed Publication of Phase 2 Clinical Trial Results for D-PLEX100 in the Prevention of Surgical Site Infections in Abdominal SurgeryPolyPid Ltd. announced the peer-reviewed publication of positive clinical data from the previously completed Phase 2 study of D-PLEX100 for the prevention of surgical site infections (SSIs) in abdominal surgery. The paper, entitled, “A prospective, randomized assessment of a novel, local antibiotic releasing platform for the prevention of superficial and deep surgical site infections,” was published in Techniques in Coloproctology, and can be found here. The Phase 2 trial was a prospective, multicenter, randomized, controlled, single-blind, two arm study and was designed to assess the efficacy and the safety of D-PLEX100 in addition to standard of care (SoC) in preventing superficial and deep SSIs in patients undergoing elective colorectal surgery. Efficacy was measured by the incidence of SSIs and mortality within 30 days post-surgery. SSIs were adjudicated by the endpoint adjudication committee, all of whom were blinded to study-group assignments. In addition, safety was assessed by the stratification and incidence of treatment-emergent adverse events. One hundred and seventy-nine patients were evaluated in the per protocol population, 88 in the intervention arm [51 males, 37 females, median age 64.0 (range: 19–92) years] and 91 in the control arm [57 males, 34 females, median age 64.5 (range: 21–88) years]. The SSI rate (superficial and deep) within 30 day post-index surgery showed a 64% statistically significant relative risk reduction in the D-PLEX100 plus SoC cohort at 8% infection rate [n=7/88] compared to 22% infection rate in the SoC alone cohort [n=20/91] (p=0.0115). There was no statistically significant difference in the incidence of treatment-emergent adverse events (TEAEs) between the two groups, and no difference in severity and incidence of serious TEAEs. No TEAEs in the D-PLEX100 plus SoC cohort were deemed related to the study drug. The appropriate next steps for PolyPid’s second Phase 3 trial of D-PLEX100 for the prevention of SSIs in abdominal surgery, SHIELD II, which incorporates broader eligibility criteria and has enrolled over 200 subjects to date, will be evaluated following the discussion with the FDA and the EU regulatory authorities. D-PLEX100, PolyPid’s lead product candidate, is designed to provide local prolonged and controlled anti-bacterial activity directly at the surgical site to prevent SSIs. Following the administration of D-PLEX100 into the surgical site, the PLEX (Polymer-Lipid Encapsulation matriX) technology pairs with Active Pharmaceutical Ingredients, enabling a prolonged and continuous release of the broad-spectrum antibiotic doxycycline, resulting in high local concentration of the drug for a period of 30 days for the prevention of SSIs, with additional potential to prevent SSIs caused by antibiotic-resistant bacteria at the surgical site. D-PLEX100 received Breakthrough Therapy Designation from the U.S. FDA for the prevention of SSIs in patients undergoing elective colorectal surgery. D-PLEX100 also received three Qualified Infectious Disease Product (QIDP) designations, and three Fast Track designations for the prevention of SSIs in patients undergoing elective colorectal surgery, post-abdominal surgery incisional infection and for the prevention of sternal wound infection post-cardiac surgery.
Price Target Changed • Sep 06Price target increased to US$24.33Up from US$21.50, the current price target is an average from 3 analysts. New target price is 2,016% above last closing price of US$1.15. Stock is down 86% over the past year. The company is forecast to post a net loss per share of US$2.04 next year compared to a net loss per share of US$2.28 last year.
공시 • Sep 04PolyPid Ltd. Announces Top-line Results of Phase 3 SHIELD I Trial of D-PLEX for the Prevention of Surgical Site Infections in Abdominal SurgeryPolyPid Ltd. announced top-line results from the SHIELD I Phase 3 study of D-PLEX(100) for the prevention of surgical site infections (SSIs) in abdominal surgery. SHIELD I (Surgical site Hospital acquired Infection prEvention with Local D-PLEX(100)) is a prospective, multinational, randomized, double-blind Phase 3 trial designed to assess the efficacy and safety of D-PLEX(100) administered concomitantly with standard of care (SoC) compared to a SoC alone arm, in the prevention of post-abdominal surgery incisional infection. The primary endpoint of the trial is the combination of incisional SSIs and mortality as measured by the proportion of subjects with either an SSI event, as determined by a blinded and independent adjudication committee, or mortality for any reason within 30 days post-surgery. The SHIELD I study is designed to demonstrate at least a 50 percent reduction in incisional SSIs in the D-PLEX(100) treatment arm compared to the control arm, with 90 percent power and a maximum alpha level of 0.0487. A total of 977 patients were randomized into the study, consisting of 488 subjects in the D-PLEX(100) treatment arm and 489 patients in the control arm. In the Intent to Treat (ITT) population, the local administration of D-PLEX(100) and SoC (n=485) resulted in a decrease in SSIs and mortality of 23 percent compared to SoC alone (n=489) (p=0.1520). Within the first 30 days post- surgery, there were 15 deaths in the SoC treatment arm, as compared to 11 in the D-PLEX(100) treatment arm. The local administration of D-PLEX(100) as compared to SoC alone also did not achieve statistical significance on the key secondary endpoint evaluating SSI events within 30 days post-abdominal index surgery. In a pre-specified subgroup ITT analysis requested by the U.S. Food and Drug Administration (FDA) of a total of 423 subjects with incision lengths >20 centimeters, the local administration of D-PLEX(100) resulted in a statistically significant reduction of 54% on the primary endpoint, compared to SoC alone (p<0.0032). Within the first 30 days post-surgery, SSIs decreased from 8.5% in the SoC treatment arm (n=211), as compared to 4.2% in the D-PLEX(100) treatment arm (n=212).
Seeking Alpha • Sep 02PolyPid sheds 75% as lead candidate fails in Phase 3 trial for post-surgical infectionsPolyPid Ltd. (NASDAQ:PYPD) dropped ~75% in value in the pre-market trading Friday after the Israeli company announced that its lead candidate D-PLEX100 did not meet the main goal in a Phase 3 trial for the prevention of surgical site infections ((SSIs)) in abdominal surgery. The SHIELD I was designed to evaluate the joint administration of D-PLEX100 standard of care (SoC) against SoC alone arm in 970 patients out of whom 488 were part of the D-PLEX100 treatment arm and 489 were in the control arm. The trial did not achieve the primary endpoint of reduction in surgical site infections and mortality, the company said noting that in the Intent to Treat (ITT) population, D-PLEX100 and SoC (n=485) led to 23% decrease in SSIs and mortality compared to SoC alone (n=489) (p=0.1520).
Seeking Alpha • Aug 10PolyPid GAAP EPS of -$1.23 misses by $0.60PolyPid press release (NASDAQ:PYPD): Q2 GAAP EPS of -$1.23 misses by $0.60. As of June 30, 2022, the Company had cash and cash equivalents and deposits in the amount of $23.8 million, not including the second tranche of $2.5 million from the Kreos Capital VI (Expert Fund) LP (“Kreos”) loan, which was drawn in July 2022.
Seeking Alpha • Aug 03PolyPid to get $2.6M upfront under license deal with Advanz for D-PLEX in EuropePolyPid (NASDAQ:PYPD) signed an exclusive licensing agreement for its lead drug candidate D-PLEX100 in Europe with U.K.-based Advanz Pharma (OTCPK:CXRXF). D-PLEX100 is used for preventing surgical site infections (SSIs) in abdominal and cardiac surgeries, in Europe. Under the agreement, PolyPid will receive $2.6M upfront and development-related milestones of up to $20.9M. Upon commercialization, PolyPid will receive up to $89M in sales-related milestones, the company said in an Aug. 3 press release. In addition, PolyPid will also supply D-PLEX100 to Advanz for a transfer price and will be entitled to royalties on net sales in double-digit percentages of up to mid-twenties. "Advanz Pharma's expertise in marketing hospital-based therapies, combined with its significant resources and relationships in the region, will prove invaluable in expanding access to D-PLEX100 and delivering this much-needed therapy, if approved, to patients," said PolyPid's CEO Dikla Czaczkes Akselbrad.
공시 • Jul 28PolyPid Ltd. to Report Q2, 2022 Results on Aug 10, 2022PolyPid Ltd. announced that they will report Q2, 2022 results Pre-Market on Aug 10, 2022
공시 • Jun 01Polypid Ltd Announces Completion of Enrollment in Phase 3 Shield I Trial of D-Plex for Prevention of Surgical Site Infections in Abdominal SurgeryPolyPid Ltd. announced the completion of enrollment in the SHIELD I Phase 3 study of D-PLEX100 for the prevention of surgical site infections (SSIs) in abdominal surgery. Following a review of unblinded efficacy data from the first 750 enrolled patients in the trial, the independent Data Safety Monitoring Board (DSMB) recently recommended concluding the study upon enrollment of 950 patients, which is the minimum number of targeted patients in the trial protocol. About SHIELD I SHIELD I (Surgical site Hospital acquired Infection prEvention with Local D-PLEX) is a prospective, multinational, randomized, double blind Phase 3 trial designed to assess the efficacy and safety of D-PLEX100 administered concomitantly with standard of care (SoC), which includes prophylactic systemic antibiotics, compared to a SoC alone arm, in prevention of post abdominal surgery incisional infection. The primary endpoint of the trial is the combination of incisional SSIs and mortality rate as measured by the proportion of subjects with either an SSIs event, as determined by a blinded and independent adjudication committee, or mortality for any reason within 30 days post-surgery. The trial has enrolled patients in more than 60 centers in the United States, Europe and Israel. About D-PLEX100 D-PLEX100, PolyPid’s lead product candidate, is designed to provide local prolonged and controlled anti-bacterial activity directly at the surgical site to prevent SSIs. Following the administration of D-PLEX100 into the surgical site, the PLEX (Polymer-Lipid Encapsulation matriX) technology pairs with Active Pharmaceutical Ingredients, enabling a prolonged and continuous release of the broad-spectrum antibiotic doxycycline, resulting in high local concentration of the drug for a period of 30 days for the prevention of SSIs, with additional potential to prevent SSIs caused by antibiotic-resistant bacteria at the surgical site. D-PLEX100 received Breakthrough Therapy Designation from the U.S. FDA for the prevention of SSIs in patients undergoing elective colorectal surgery. D-PLEX100 also received three Qualified Infectious Disease Product (QIDP) designations, and three Fast Track designations for the prevention of SSIs in patients undergoing elective colorectal surgery, post-abdominal surgery incisional infection and for the prevention of sternal wound infection post-cardiac surgery.
공시 • May 24PolyPid Ltd. Announces Recommendation by Data Safety Monitoring Board to Conclude Enrollment of Phase 3 SHIELD I Trial of D-PLEX at the Minimum Number of Patients Targeted Following Unblinded Interim Efficacy AnalysisPolyPid Ltd. announced that following the independent Data Safety Monitoring Board (DSMB) review of unblinded efficacy data from the first 750 enrolled patients in the SHIELD I Phase 3 study of D-PLEX100 for the prevention of surgical site infections (SSIs) in abdominal tissue surgery, the recommendation was to conclude the study upon enrollment of 950 patients, which is the minimum number of targeted patients in the study protocol. The enrollment of the 950th patient is expected to occur within days. The SHIELD I study is designed to demonstrate at least a 50% reduction in incisional SSIs in the D-PLEX100 treatment arm compared to the control arm, with 90% power and a maximum alpha level of 0.04. The Company anticipates reporting top-line results by the end of the third quarter of 2022, followed by a potential New Drug Application (NDA) submission to the U.S. Food and Drug Administration (FDA) and a European Union Marketing Authorization Application (MAA) filing, both targeted for the first half of 2023. SHIELD I (Surgical site Hospital acquired Infection prEvention with Local D-PLEX) is a prospective, multinational, randomized, double blind Phase 3 trial designed to assess the efficacy and safety of D-PLEX100 administered concomitantly with standard of care (SoC), which includes prophylactic systemic antibiotics, compared to a SoC alone arm, in prevention of post abdominal surgery incisional infection. The primary endpoint of the trial is the combination of incisional SSIs and mortality rate as measured by the proportion of subjects with either an SSIs event, as determined by a blinded and independent adjudication committee, or mortality for any reason within 30 days post-surgery. The trial has enrolled patients in more than 60 centers in the United States, Europe and Israel. D-PLEX100, PolyPid’s lead product candidate, is designed to provide local prolonged and controlled anti-bacterial activity directly at the surgical site to prevent SSIs. Following the administration of D-PLEX100 into the surgical site, the PLEX (Polymer-Lipid Encapsulation matriX) technology pairs with Active Pharmaceutical Ingredients, enabling a prolonged and continuous release of the broad-spectrum antibiotic doxycycline, resulting in high local concentration of the drug for a period of four weeks for the prevention of SSIs, with additional potential to prevent SSIs caused by antibiotic-resistant bacteria at the surgical site. D-PLEX100 received Breakthrough Therapy Designation from the U.S. FDA for the prevention of SSIs in patients undergoing elective colorectal surgery. D-PLEX100 also received three Qualified Infectious Disease Product (QIDP) designations, and three Fast Track designations for the prevention of SSIs in patients undergoing elective colorectal surgery, post-abdominal surgery incisional infection and for the prevention of sternal wound infection post-cardiac surgery.
공시 • May 12PolyPid Ltd. Announces Executive ChangesPolyPid Ltd. strengthened the executive management team with the recent appointment of Evgeny Valdman as Company's new Executive Vice President of Operations and the promotion of Dalit Hazan to Executive Vice President, Research & Development, and Clinical & Regulatory Affairs. Evgeny brings to PolyPid more than 25 years of experience in senior management positions at Teva Pharmaceuticals and other pharmaceutical companies with approved products, with success at all levels of operations. Since 2016, Ms. Hazan has served in various leadership roles at PolyPid, most recently as PolyPid’s Senior Vice President, Research and Development and Regulatory Affairs.
Seeking Alpha • Apr 19PolyPid: Strong Pipeline, Close CatalystsPolyPid develops a platform technology to provide locally controlled and continuous delivery of medications. Lead product candidate D-PLEX100 is investigated for the prevention of sternal and abdominal surgical site infections serving a huge market. Meaningful interim results and topline data from pivotal Phase 3 SHIELD I clinical trial will soon be published. Measured in terms of the clinical benefit of D‑PLEX100 and its estimated market size, PolyPid is clearly undervalued at present in our view.
공시 • Apr 07PolyPid Ltd. announced that it expects to receive $15 million in funding from Kreos Capital Management (UK) LimitedPolyPid Ltd. entered into a secured loan agreement with new lender Kreos Capital VI (Expert Fund) L.P., a fund managed by Kreos Capital Management (UK) Limited for up to $15 million on April 6, 2022. The loan facility is comprised of three tranches in the amount of $10 million, $2.5 million, and $2.5 million, respectively, with the completion of the first tranche available upon the execution of the agreement. The second tranche of $2.5 million will be available subject to obtaining positive results from the planned unblinded interim analysis of the company’s ongoing Phase 3 trial of D-PLEX100 for the prevention of abdominal soft tissue SSIs, SHIELD I, which will be conducted following the 30-day follow-up assessment for the recently enrolled 750th patient that is expected in the second quarter of this year. Completion of the third and final tranche of $2.5 million will be available subject to obtaining positive top-line results from the SHIELD I trial or if other conditions are met. Completion of the second and third tranches can be made by December 31, 2022. The loan agreement provides for interest-only repayments of the first tranche until December 31, 2022, followed by 36 equal monthly repayments of principal and interest. For the second and third tranches, if drawn, the company will make repayments of interest only until August 31, 2023, followed by 33 equal monthly repayments of principal and interest. The senior secured loan initially bears interest at a rate of 9.25%, which may be reduced to 8.75% upon reaching certain milestones. The loan is prepay able in full, at any time at the option of the company. The company will also issue a 7-year warrant to the investor to purchase the company’s ordinary shares equal to 8% of the amount of each tranche, if borrowed, with an exercise price of $5.135 per share.
공시 • Mar 29PolyPid Ltd., Annual General Meeting, May 03, 2022PolyPid Ltd., Annual General Meeting, May 03, 2022, at 11:00 Israel Standard Time. Location: 18 Hasivim Street, Petach 495376 Tikva Israel Agenda: To re-appoint Kost Forer Gabbay & Kasierer, Certified Public Accountants, as the independent registered public accountants of the company, and to authorize the board of directors of the company to determine their compensation; to re- elect seven members of the board of directors of the company and approve their compensation; to approve an option grant and a retirement package for the company’s currently serving Chief Executive Officer, Mr. Amir Weisberg; to approve the terms of employment for Ms. Dikla Czaczkes Akselbrad as the company’s new Chief Executive Officer; to approve an amendment to the company's Articles of Association; to discuss the company’s financial statements for the fiscal year ended December 31, 2021.
분석 기사 • Mar 18Will PolyPid (NASDAQ:PYPD) Spend Its Cash Wisely?We can readily understand why investors are attracted to unprofitable companies. For example, biotech and mining...
공시 • Mar 04PolyPid Ltd. Announces 750Th Patient Enrolled in Shield I Phase 3 Clinical Trial of D-Plex100 in Abdominal SurgeryPolyPid Ltd. announced that the 750th patient has been enrolled into its ongoing pivotal Phase 3 SHIELD I study evaluating D-PLEX100 for the prevention of surgical site infections (SSIs) in abdominal surgery. Upon completion of the 30-day follow-up assessment for the 750th patient, based on an agreement with the U.S. Food and Drug Administration (FDA), an unblinded interim analysis will be conducted. This interim analysis is expected to occur during the second quarter of this year, and will allow for early trial conclusion due to efficacy, futility, or for sample size re-assessment. The FDA has previously agreed, provided the Phase 3 study results are adequate, that a single pivotal study is sufficient for potential approval of D-PLEX100 for the prevention of SSIs in colorectal (abdominal) surgery.
공시 • Feb 10PolyPid Ltd. Announces CEO ChangesPolyPid Ltd. announced that Board of Directors appointed Dikla Czaczkes Akselbrad, currently Executive Vice President and Chief Financial Officer of the Company, as PolyPid’s Chief Executive Officer, effective July 1, 2022, at which time Amir Weisberg will retire from his position as Chief Executive Officer.
분석 기사 • Nov 08Here's Why We're Watching PolyPid's (NASDAQ:PYPD) Cash Burn SituationWe can readily understand why investors are attracted to unprofitable companies. For example, although...
공시 • Sep 15PolyPid Announces Positive Preclinical Data of its Intra-tumoral OncoPLEX in Brain CancerPolyPid Ltd. announced positive preclinical data in two key Glioblastoma Multiform (GBM) animal models of its OncoPLEX intra-tumoral cancer therapy program. OncoPLEX utilizes the Company’s novel PLEX technology to provide controlled local exposure to docetaxel, one of the most widely used chemotherapy agents, for a few weeks in the intra-operative tumor resection setting, to potentially reduce local tumor recurrence, tumor spreading and prolong patient survival. The OncoPLEX intra-tumoral cancer therapy program was evaluated in brain tumors for tumor growth and survival in two Glioblastoma Multiform (GBM) animal models. Key results included: OncoPLEX induced strong inhibition of tumor growth and recurrence in a partially resected human glioblastoma subcutaneous mouse model. A single local OncoPLEX application induced 98% tumor growth inhibition (day 41 post operation) compared to the untreated control (p<0.001), and 66% compared to multiple injections of systemic chemotherapy treatment arm (p=0.0165). The day 41 survival rate for OncoPLEX was much higher than the systemic treated mice, or untreated with 60%, 20%, and 10% survival, respectively. OncoPLEX was also tested in a GBM brain rat model. OncoPLEX, applied locally next to the non-resected tumor in the brain, showed a 40% survival rate at day 23 following the beginning of treatment, as compared to a 0% survival rate in the standard systemic treatment arm (Temozolomide 33.5 mg/kg, 5 treatment days), the placebo arm (OncoPLEX without Docetaxel) and in the untreated control arm. Only OncoPLEX significantly enhanced the overall survival compared to both the placebo arm and to the untreated arm (p<0.02). Dose response was demonstrated for OncoPLEX in the different animal models. Local application of OncoPLEX in a rat brain model evidenced good safety profile at the different doses studied.
분석 기사 • Jul 15We Think PolyPid (NASDAQ:PYPD) Can Afford To Drive Business GrowthThere's no doubt that money can be made by owning shares of unprofitable businesses. For example, although...
공시 • May 20PolyPid Ltd. Announces Positive FDA Type B Meeting Feedback for D-Plex Development ProgramPolyPid Ltd. announced it has received written responses from the U.S. Food and Drug Administration (FDA) to a Type B meeting request that the Company submitted regarding its development plan for D-PLEX100. The FDA indicated that PolyPid’s proposal for a single Phase 3 pivotal study (SHIELD I), provided the study results are adequate, would provide sufficient evidence of clinical efficacy and safety to support approval of D-PLEX100 for the prevention of surgical site infections (SSIs) in colorectal surgery. The Type B meeting was requested following PolyPid’s receipt of Breakthrough Therapy Designation from the FDA for D-PLEX100 for the prevention of SSIs in patients undergoing elective colorectal surgery. Launched in July 2020, SHIELD I is a prospective, multinational, multicenter, randomized, double blind Phase 3 trial designed to assess the efficacy and safety of D-PLEX100 for the prevention of incisional SSIs post-abdominal surgery. The primary endpoint of the trial is the combination of incisional SSIs and mortality rate as measured by the proportion of subjects with either an SSI event, as determined by a blinded and independent adjudication committee, or mortality for any reason within 30 days post-surgery. The trial will enroll a minimum of 616 patients, with a maximum of about 900 patients, as defined by the adaptive study design, in more than 60 centers in the United States, Europe and Israel.
분석 기사 • Mar 09Here's Why We're Not Too Worried About PolyPid's (NASDAQ:PYPD) Cash Burn SituationEven when a business is losing money, it's possible for shareholders to make money if they buy a good business at the...
공시 • Mar 06PolyPid Ltd., Annual General Meeting, Apr 13, 2021PolyPid Ltd., Annual General Meeting, Apr 13, 2021, at 11:00 Israel Standard Time. Location: 18 Hasivim Street Petach Tikva Israel Agenda: To re-appoint Kost Forer Gabbay & Kasierer, Certified Public Accountants (Isr.), a member firm of EY Global, as independent registered public accountants of the Company; to re-appoint nine members of the Board of Directors of the Company; to approve a bonus and certain terms of compensation of Mr. Amir Weisberg, the Company’s Chief Executive Officer and director; to approve an increase in the annual fee of the Chairman of the Board of Directors; and to consider other matters.
공시 • Feb 18Polypid Ltd. Announces 100Th Patient Enrolled in Shield I Phase 3 Clinical Trial of D-Plex100 for the Prevention of Post-Abdominal Surgery Incisional InfectionsPolyPid Ltd. announced that the 100th patient has been enrolled and randomized in the SHIELD I (Surgical site Hospital acquired Infection prEvention with Local D-plex) trial, the Company’s first of two Phase 3 clinical trials for its lead product candidate, D-PLEX100, for the prevention of post-abdominal surgery incisional infections (soft tissue). SHIELD I is a prospective, multinational, multicenter, randomized, double blind Phase 3 trial designed to assess the efficacy and safety of D-PLEX100 in the prevention of incisional surgical site infections (SSIs) post-abdominal surgery. The primary endpoint of the trial is the combination of incisional SSIs and mortality rate as measured by the proportion of subjects with either an SSIs event, as determined by a blinded and independent adjudication committee, or mortality for any reason within 30 days post-surgery. The trial will enroll a minimum of 616 patients, with a maximum of about 900 patients, as defined by the adaptive study design, in more than 60 centers in the United States, Europe and Israel.
Is New 90 Day High Low • Feb 10New 90-day high: US$12.75The company is up 34% from its price of US$9.51 on 11 November 2020. The American market is up 15% over the last 90 days, indicating the company outperformed over that time. It also outperformed the Pharmaceuticals industry, which is up 8.0% over the same period.
공시 • Jan 28PolyPid Ltd. to Report Q4, 2020 Results on Feb 10, 2021PolyPid Ltd. announced that they will report Q4, 2020 results Pre-Market on Feb 10, 2021
공시 • Dec 23PolyPid Announces Positive Preclinical Data from OncoPLEX Intra-Tumoral Cancer Therapy ProgramPolyPid Ltd. announced positive preclinical data from its OncoPLEX intra-tumoral cancer therapy program. OncoPLEX utilizes the Company’s novel PLEX technology to provide prolonged and controlled local exposure to docetaxel, one of the most widely used chemotherapy agents, in the intra-operative tumor resection setting. OncoPLEX is designed for the delivery of sustained, significant concentrations of docetaxel locally within the tumor site for a few weeks, potentially reducing local tumor recurrence and tumor metastatic spreading. In a syngeneic mouse model for solid tumors of colon carcinoma, a single local application of OncoPLEX at the intra-operative setting post tumor resection compared to the group treated with six cycles of systemic docetaxel treatment with 2-4 days gap between cycles, generated the following key results: OncoPLEX arm showed 25% overall tumor recurrence at the end of the study (day 39 post-surgery) compared to 75% in the systemic treatment arm, and 100% in the untreated control arm. OncoPLEX arm demonstrated 75% overall tumor free survival at the end of the study (day 39 post-surgery), compared to 25% in the systemic treatment arm, and 0% in the untreated control arm. OncoPLEX arm demonstrated 75% overall survival at the end of the study (day 39 post-surgery), compared to 50% in the systemic treatment arm, and 0% in the untreated control arm. Dose response was also demonstrated for OncoPLEX in these studies. Systemic toxicity was lower following the local application of OncoPLEX versus systemic docetaxel. Additional data in a pharmacokinetic model showed that the maximal plasma concentration of docetaxel was >10 times lower with OncoPLEX than with systemic docetaxel. Based on these compelling preclinical results, PolyPid intends to conduct additional preclinical safety studies of OncoPLEX in various type of solid tumor resections, in order to complete a preclinical package for the filing of pre-Investigational New Drug meeting request with the U.S. Food and Drug Administration in 2021 and potentially initiate a Phase 1 clinical trial in 2022.
공시 • Dec 18PolyPid Initiates SHIELD II: Second Phase 3 Clinical Trial of D-PLEX100 for the Prevention of Post-Abdominal Surgery Incisional InfectionsPolyPid Ltd. announced that the first patient has been enrolled and randomized in the SHIELD II (Surgical site Hospital acquired Infection prEvention with Local D-plex) trial, the Company’s second of two Phase 3 clinical trials for its lead product candidate, D-PLEX100, for the prevention of post-abdominal surgery incisional infection (soft tissue). SHIELD II (NCT04411199) is a prospective, multinational, multicenter, randomized, double-blind Phase 3 trial designed to assess the efficacy and safety of D-PLEX100 administered concomitantly with the Standard of Care (SoC), compared to a SoC-treated control arm, for the prevention of post-abdominal surgery incisional infection. The primary endpoint of the trial is the infection rate, as measured by the proportion of subjects with at least one abdominal target incisional infection event within 30 days post-abdominal surgery, determined by a blinded independent adjudication committee. The trial will enroll a minimum of 900 patients, with a maximum of approximately 1,400 subjects, as defined by the adaptive study design, in approximately 60 centers in the United States, Europe and Israel.
Is New 90 Day High Low • Nov 07New 90-day low: US$9.98The company is down 30% from its price of US$14.21 on 07 August 2020. The American market is up 6.0% over the last 90 days, indicating the company underperformed over that time. It also underperformed the Pharmaceuticals industry, which is down 2.0% over the same period. According to the Simply Wall St valuation model, the estimated intrinsic value of the company is per share.
공시 • Oct 29PolyPid Ltd. to Report Q3, 2020 Results on Nov 11, 2020PolyPid Ltd. announced that they will report Q3, 2020 results at 9:00 AM, Israel Standard Time on Nov 11, 2020
Is New 90 Day High Low • Sep 28New 90-day low: US$11.00The company is down 39% from its price of US$18.03 on 30 June 2020. The American market is up 9.0% over the last 90 days, indicating the company underperformed over that time. It also underperformed the Pharmaceuticals industry, which is up 4.0% over the same period. According to the Simply Wall St valuation model, the estimated intrinsic value of the company is per share.
공시 • Aug 07PolyPid Ltd. to Report Q2, 2020 Results on Aug 19, 2020PolyPid Ltd. announced that they will report Q2, 2020 results at 9:00 AM, Israel Standard Time on Aug 19, 2020
