PolyPid Overview
PolyPid is a late-stage biopharmaceutical company focused on improving surgical outcomes. Through locally administered, controlled, prolonged-release therapeutics, PolyPid’s proprietary PLEX (Polymer-Lipid Encapsulation matriX) technology pairs with active pharmaceutical ingredients to enable the precise delivery of drugs at optimal release rates over durations ranging from days to months. PolyPid’s lead product candidate, D-PLEX100, is in a phase 3 clinical trial for the prevention of abdominal colorectal surgical site infections. In addition, the company’s OncoPLEX is currently in preclinical stage testing for the treatment of solid tumors, beginning with glioblastomas.
Cumulative Funding Raised Over Time ($)
$12.5MApr 2022
$20.6MAug 2024
$35.1MDec 2024
$57.1MFeb 2016
$65.2MFeb 2016
$66.6MJan 2010
$68.6MJan 2012
$84.8MJan 2024
$111.5MJun 2025
$116.8MNov 2016
$131.8MNov 2018
$181.8MSep 2019
Latest News
growth-positive
PolyPid to Report Third Quarter 2025 Financial Results and Operational Highlights on November 12, 2025
PolyPid Ltd., a late-stage biopharma company, announced it will report its third quarter 2025 financial results and operational highlights on November 12, 2025. The company will host a conference call to discuss these results and provide updates on business operations. PolyPid is focused on improving surgical outcomes through its PLEX technology, which allows for controlled, prolonged-release of therapeutics. The company plans to submit a New Drug Application for its lead product, D-PLEX100, aimed at preventing abdominal colorectal surgical site infections, in early 2026. PolyPid also has a pipeline in oncology, obesity, and diabetes.
Product StageFDA approved/pending approval
growth-positive
PolyPid to Present Its Positive Phase 3 SHIELD II Topline Results at the 2025 American College of Surgeons Clinical Congress
PolyPid Ltd., a late-stage biopharma company, announced the successful results of its Phase 3 SHIELD II trial for D-PLEX₁₀₀, a novel prolonged-release doxycycline for surgical site infection prophylaxis. The trial demonstrated significant reductions in surgical site infections and related complications. These results will be presented at the 2025 American College of Surgeons Clinical Congress. Following these positive outcomes, PolyPid plans to submit a New Drug Application for D-PLEX₁₀₀ in early 2026. The company is also developing a pipeline in oncology, obesity, and diabetes, leveraging its proprietary PLEX technology for controlled drug delivery.
Product StageFDA approved/pending approval
growth-positive
PolyPid to Present at Lytham Partners Fall 2025 Investor Conference and Participate in 4th Annual ROTH Healthcare Opportunities Conference
PolyPid Ltd., a late-stage biopharma company, announced its participation in the Lytham Partners Fall 2025 Virtual Investor Conference and the 4th Annual ROTH Healthcare Opportunities Conference. The company aims to improve surgical outcomes through its proprietary PLEX technology, which enables precise drug delivery. Following positive phase 3 results, PolyPid plans to submit a New Drug Application (NDA) for its lead product candidate, D-PLEX100, in early 2026. The company is also developing an innovative pipeline in oncology, obesity, and diabetes. These developments indicate a growth-positive outlook for PolyPid as it advances its product offerings and engages with investors.
Product StageManagement Changes
growth-positive
PolyPid Successfully Completes Israeli Ministry of Health GMP Inspection, Advancing Towards Commercial Manufacturing Readiness for D-PLEX₁₀₀
PolyPid Ltd., a late-stage biopharma company, has successfully completed a Good Manufacturing Practice (GMP) inspection by the Israeli Ministry of Health, marking the fourth consecutive successful inspection of its manufacturing facility. This milestone strengthens PolyPids position as it advances towards the global commercialization of its lead product candidate, D-PLEX₁₀₀, following successful Phase 3 SHIELD II trial results. The inspection confirms the companys readiness for commercial production in the European market and prepares it for a future FDA facility inspection in the U.S. D-PLEX₁₀₀ is designed to prevent surgical site infections and has received Breakthrough Therapy designation from the FDA.
Product Stage
growth-positive
PolyPid to Participate in the Upcoming 27th Annual H.C. Wainwright Global Investment Conference
PolyPid Ltd., a late-stage biopharma company, announced its participation in the 27th Annual H.C. Wainwright Global Investment Conference in New York City on September 8-9, 2025. The company aims to improve surgical outcomes through its proprietary PLEX technology, which enables precise drug delivery. PolyPid plans to submit a New Drug Application for its lead product, D-PLEX100, in early 2026 following positive phase 3 results. The company also has a pipeline in oncology, obesity, and diabetes. During the conference, PolyPids management will engage in one-on-one investor meetings, signaling potential investment opportunities.
Product StageInvestment
| Sector | Health Tech & Life Sciences |
Funding
| Total funding | $239.24M |
| Last funding | $26.7M |
| Stage | Public |
| Rounds | 14 |
| Investors | 7 |
Team Members
4
Employees: 51-200
Web & Social Links
| Website | www.polypid.com |
| Careers | Careers page |
Locations
HaSivim Street 18, Petah Tikva, Israel
Photos & Videos
1 item(s)
PolyPid Business
Business models
B2C, B2B2C
Product stage
Clinical Trial
Employees
51-200
Sector
Health Tech & Life SciencesPharma & Medical BiotechnologyDrug DeliveryTarget Customer
Healthcare & Life SciencesLife SciencesPharmaceuticalsCore Technology
BiologicalsMoleculesTags (10)
orthopedicsdentaldrug-deliverypharma-companiessustained-releasetherapeuticspain-reliefcancerbiopharmaceuticalsurgeonsGeographic Markets
EuropeUnited StatesPolyPid Financials
$239.24M
Total funding
Undisclosed
Capital raised
$26.7M
Last funding
Public
Funding stage
14
Total rounds
7
Investors
Cumulative Funding Raised Over Time ($)
$12.5MApr 2022
$20.6MAug 2024
$35.1MDec 2024
$57.1MFeb 2016
$65.2MFeb 2016
$66.6MJan 2010
$68.6MJan 2012
$84.8MJan 2024
$111.5MJun 2025
$116.8MNov 2016
$131.8MNov 2018
$181.8MSep 2019
Private Equity Funding
PIPE
Jun 2025
$26.7M
PIPE
Dec 2024
$14.5M
PIPE
Aug 2024
$8.1M
Undisclosed Investor(s)
PIPE
Jan 2024
$16.2M
Rosalind Advisors, DAFNA Capital Management
Debt Financing
Apr 2022
$12.5M
Kreos Capital
E Round
Sep 2019
$50M
E Round
Nov 2018
$15M
Debt Financing
Nov 2016
$5.3M
D Round
Feb 2016
$22M
Shavit Capital Fund (Lead)
,
Chaim Hurvitz, Aurum Ventures M.K.I
C Round
Feb 2016
$8.14M
Aurum Ventures M.K.I, Shavit Capital Fund
B Round
Jan 2012
$2M
A Round
Jan 2010
$1.4M
Public Offering / Exit
POEvent
Mar 2023
Undisclosed
POEvent
Jun 2020
Undisclosed
PolyPid Lifecycle
Cumulative Funding Raised Over Time
$12.5MApr 2022
$20.6MAug 2024
$35.1MDec 2024
$57.1MFeb 2016
$65.2MFeb 2016
$66.6MJan 2010
$68.6MJan 2012
$84.8MJan 2024
$111.5MJun 2025
$116.8MNov 2016
$131.8MNov 2018
$181.8MSep 2019
All Events
PIPE
Jun 2025
$26.7M
PIPE
Dec 2024
$14.5M
PIPE
Aug 2024
$8.1M
Undisclosed Investor(s)
PIPE
Jan 2024
$16.2M
Rosalind Advisors, DAFNA Capital Management
Debt Financing
Apr 2022
$12.5M
Kreos Capital
E Round
Sep 2019
$50M
E Round
Nov 2018
$15M
Debt Financing
Nov 2016
$5.3M
D Round
Feb 2016
$22M
Shavit Capital Fund (Lead)
,
Chaim Hurvitz, Aurum Ventures M.K.I
C Round
Feb 2016
$8.14M
Aurum Ventures M.K.I, Shavit Capital Fund
B Round
Jan 2012
$2M
A Round
Jan 2010
$1.4M
POEvent
Mar 2023
Undisclosed
POEvent
Jun 2020
Undisclosed
PolyPid News
131 articles
growth-positive
PolyPid to Report Third Quarter 2025 Financial Results and Operational Highlights on November 12, 2025
PolyPid Ltd., a late-stage biopharma company, announced it will report its third quarter 2025 financial results and operational highlights on November 12, 2025. The company will host a conference call to discuss these results and provide updates on business operations. PolyPid is focused on improving surgical outcomes through its PLEX technology, which allows for controlled, prolonged-release of therapeutics. The company plans to submit a New Drug Application for its lead product, D-PLEX100, aimed at preventing abdominal colorectal surgical site infections, in early 2026. PolyPid also has a pipeline in oncology, obesity, and diabetes.
Product StageFDA approved/pending approval
growth-positive
PolyPid to Present Its Positive Phase 3 SHIELD II Topline Results at the 2025 American College of Surgeons Clinical Congress
PolyPid Ltd., a late-stage biopharma company, announced the successful results of its Phase 3 SHIELD II trial for D-PLEX₁₀₀, a novel prolonged-release doxycycline for surgical site infection prophylaxis. The trial demonstrated significant reductions in surgical site infections and related complications. These results will be presented at the 2025 American College of Surgeons Clinical Congress. Following these positive outcomes, PolyPid plans to submit a New Drug Application for D-PLEX₁₀₀ in early 2026. The company is also developing a pipeline in oncology, obesity, and diabetes, leveraging its proprietary PLEX technology for controlled drug delivery.
Product StageFDA approved/pending approval
growth-positive
PolyPid to Present at Lytham Partners Fall 2025 Investor Conference and Participate in 4th Annual ROTH Healthcare Opportunities Conference
PolyPid Ltd., a late-stage biopharma company, announced its participation in the Lytham Partners Fall 2025 Virtual Investor Conference and the 4th Annual ROTH Healthcare Opportunities Conference. The company aims to improve surgical outcomes through its proprietary PLEX technology, which enables precise drug delivery. Following positive phase 3 results, PolyPid plans to submit a New Drug Application (NDA) for its lead product candidate, D-PLEX100, in early 2026. The company is also developing an innovative pipeline in oncology, obesity, and diabetes. These developments indicate a growth-positive outlook for PolyPid as it advances its product offerings and engages with investors.
Product StageManagement Changes
growth-positive
PolyPid Successfully Completes Israeli Ministry of Health GMP Inspection, Advancing Towards Commercial Manufacturing Readiness for D-PLEX₁₀₀
PolyPid Ltd., a late-stage biopharma company, has successfully completed a Good Manufacturing Practice (GMP) inspection by the Israeli Ministry of Health, marking the fourth consecutive successful inspection of its manufacturing facility. This milestone strengthens PolyPids position as it advances towards the global commercialization of its lead product candidate, D-PLEX₁₀₀, following successful Phase 3 SHIELD II trial results. The inspection confirms the companys readiness for commercial production in the European market and prepares it for a future FDA facility inspection in the U.S. D-PLEX₁₀₀ is designed to prevent surgical site infections and has received Breakthrough Therapy designation from the FDA.
Product Stage
growth-positive
PolyPid to Participate in the Upcoming 27th Annual H.C. Wainwright Global Investment Conference
PolyPid Ltd., a late-stage biopharma company, announced its participation in the 27th Annual H.C. Wainwright Global Investment Conference in New York City on September 8-9, 2025. The company aims to improve surgical outcomes through its proprietary PLEX technology, which enables precise drug delivery. PolyPid plans to submit a New Drug Application for its lead product, D-PLEX100, in early 2026 following positive phase 3 results. The company also has a pipeline in oncology, obesity, and diabetes. During the conference, PolyPids management will engage in one-on-one investor meetings, signaling potential investment opportunities.
Product StageInvestment
growth-positive
PolyPid to Present at the 14th Meeting of the Israel Controlled Release Society Conference
PolyPid Ltd., a late-stage biopharma company, announced that its Deputy CEO, Dalit Hazan, will present at the Israel Controlled Release Society Conference in September 2025. The presentation will focus on PolyPids novel drug delivery platform, which has successfully completed Phase III trials. The company plans to submit a New Drug Application (NDA) for its lead product, D-PLEX100, aimed at preventing surgical site infections, in early 2026. PolyPids proprietary PLEX technology enables precise drug delivery over extended periods, and the company is also developing treatments in oncology, obesity, and diabetes.
Product StageFDA approved/pending approval
growth-positive
PolyPid Ltd (PYPD) Q2 2025 Earnings Call Highlights: Strategic Advances Amid Rising Expenses
PolyPid Ltd reported successful results from its SHIELD II Phase 3 trial, showing significant clinical benefits of D-PLEX100 in preventing surgical site infections. The trial demonstrated a 58% reduction in infections compared to standard care. The company plans a pre-NDA meeting with the FDA by the end of the year and aims for NDA submission in early 2026. Despite a net loss of $10 million in Q2 2025, up from $6.3 million in Q2 2024, PolyPid has strengthened its financial position with a total cash position of $29.5 million as of June 30, 2025. The company faces uncertainties related to regulatory approvals.
Product StageInvestment
growth-positive
PolyPid Provides Corporate Update and Reports Second Quarter 2025 Financial Results
PolyPid Ltd., a late-stage biopharma company, announced positive results from its Phase 3 SHIELD II trial for D-PLEX₁₀₀, showing a 58% reduction in surgical site infections. The company plans to submit a New Drug Application to the FDA in early 2026. PolyPid is also advancing its GLP-1 receptor agonists delivery platform targeting obesity and diabetes. The company strengthened its financial position through a successful warrant exercise and appointed Dr. Nurit Tweezer-Zaks as the new Chief Medical Officer. PolyPid is in discussions with potential partners in the U.S. to maximize market potential for D-PLEX₁₀₀.
Product StageManagement ChangesPartners
growth-positive
PolyPid Appoints Dr. Nurit Tweezer-Zaks as Chief Medical Officer
PolyPid Ltd., a late-stage biopharma company, announced the appointment of Dr. Nurit Tweezer-Zaks as Chief Medical Officer, effective August 18, 2025. Dr. Tweezer-Zaks transitions from the companys Board of Directors to lead the medical strategy following positive Phase 3 trial results. Her appointment comes as PolyPid prepares for a New Drug Application submission and advances its pipeline, including a new GLP-1 program. Dr. Tweezer-Zaks brings extensive experience from her previous roles at MediCane Health Inc., aMOON Venture Capital Fund, and Sanofi. Her leadership is expected to be instrumental in addressing unmet medical needs in surgical care, oncology, and metabolic diseases.
Management ChangesProduct Stage
growth-positive
PolyPid to Report Second Quarter 2025 Financial Results and Operational Highlights on August 13, 2025
PolyPid Ltd., a late-stage biopharma company, announced plans to report its second quarter 2025 financial results and operational highlights on August 13, 2025. The company, which focuses on improving surgical outcomes through its PLEX technology, is preparing for a New Drug Application (NDA) submission for its lead product candidate, D-PLEX100, aimed at preventing abdominal colorectal surgical site infections. This follows positive phase 3 results. PolyPid also has a pipeline in oncology, obesity, and diabetes. The announcement is seen as growth-positive, highlighting the companys progress and future plans.
Product Stage
growth-positive
PYPD: Positive Topline Data From D-PLEX₁₀₀ Trial Contributes to Multiple Subsequent Benefits
PolyPid Ltd., a biopharmaceutical company, has achieved significant milestones in its Phase 3 clinical trial for D-PLEX₁₀₀, a product designed to prevent surgical site infections (SSIs) in abdominal surgeries. The SHIELD II trial, which enrolled 800 patients across the U.S., Europe, and Israel, demonstrated that D-PLEX₁₀₀ met both primary and key secondary efficacy endpoints. The trial showed a statistically significant reduction in SSIs, with a 58% decrease in infection rates compared to standard care alone. These results highlight the potential of PolyPids PLEX technology to enhance surgical outcomes by providing prolonged-release therapeutics directly at the surgical site.
Product Stage
growth-positive
PolyPid Unveils a Long-Acting GLP-1 Receptor Agonists Delivery Platform Targeting the Diabetes and Weight Loss Market
PolyPid Ltd., a late-stage biopharma company, has unveiled a new GLP-1 receptor agonists delivery platform that can release GLP-1 for approximately 60 days, significantly longer than the current weekly injection regimens. This innovation could transform patient care in diabetes and weight management markets, potentially eliminating the need for weekly injections. The companys proprietary drug delivery system, which has been clinically validated in over 1,000 patients, aims to improve medication adherence and patient outcomes. PolyPids technology uses a polymer-lipid based matrix for controlled drug delivery over prolonged periods. The company is also preparing for a New Drug Application submission for its lead product candidate, D-PLEX100, in early 2026.
Product Stage
growth-positive
Finance Herald Publishes Coverage of PolyPid's Groundbreaking New 60-Day GLP-1 Delivery Tech
PolyPid Ltd., an Israeli biotech company, has announced a breakthrough in the development of a long-acting GLP-1 receptor agonist delivery platform. This technology can maintain therapeutic levels for approximately 60 days from a single subcutaneous administration, potentially reducing the frequency of injections from weekly to just six times a year. This development positions PolyPid as a significant player in the GLP-1 market, which is projected to reach $100 billion. The announcement follows recent high-value deals in the industry, such as Eli Lillys $870 million collaboration with Camurus and Novo Nordisks $285 million deal with Ascendis Pharma. PolyPids technology is built on their proprietary PLEX technology, which has already succeeded in Phase 3 clinical trials.
Product StageAcquisition
growth-positive
Analysts Predict Up to ~590% Spike for These 2 ‘Strong Buy’ Penny Stocks
Skye Bioscience, a biopharmaceutical company, is developing innovative treatments for metabolic disorders, focusing on obesity. Their lead candidate, nimacimab, is a CB1 inhibitor currently in Phase 2a clinical trials. The drug aims to address obesity by targeting the CB1 pathway while avoiding central nervous system side effects. Early trials have shown promising results, with significant weight loss observed in preclinical and Phase 1 studies. The company anticipates releasing topline data in late Q3 or early Q4 2025. The global anti-obesity drug market is expected to grow significantly, providing a fertile ground for Skyes innovative approach.
Product StageInvestment
growth-positive
PolyPid Secures $26.7 Million Through Warrant Exercise Following Successful SHIELD II Phase 3 Trial Results
PolyPid Ltd., a late-stage biopharma company, has secured $26.7 million through the exercise of warrants. This funding is expected to extend the companys financial runway beyond the anticipated FDA approval of its product, D-PLEX₁₀₀, which recently showed successful results in a Phase 3 trial. The funding involves agreements with holders of existing warrants, allowing them to purchase shares at a set price. The proceeds will be used for the companys new drug application submission, launch preparations, and general corporate purposes. The transaction is expected to close on June 18, 2025.
Investment
growth-positive
The Israeli company's treatment is a delayed-release antibiotic administered in the area where the patient has undergone surgery.
PolyPid, an Israeli biopharmaceutical company, has reported positive results from its Phase III trial for a delayed-release antibiotic treatment aimed at preventing surgical infections. This marks a significant turnaround from a previous failed trial in 2022, which had negatively impacted the companys stock. The new trial, focusing on patients with large incisions, showed a 58% reduction in infection risk. PolyPid plans to submit for FDA approval by early 2026 and is seeking partners to market the product in the US. The company has already secured a marketing agreement with Advanz Pharma for the European market. PolyPid has raised approximately $240 million to date, with continued support from investors like Morris Kahn and Aurum Ventures.
Product StagePartnersInvestment
growth-positive
PolyPid 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 Endpoints
PolyPid Ltd. announced positive topline results from its pivotal SHIELD II Phase 3 trial of D-PLEX100, aimed at preventing surgical site infections (SSIs) in patients undergoing abdominal colorectal surgery. The trial met its primary and secondary efficacy endpoints, demonstrating a significant reduction in SSI rates. PolyPid plans to submit a New Drug Application to the FDA in early 2026, with a Marketing Authorization Application in the EU to follow. The results are expected to advance global partnership discussions and target a U.S. market of over 12 million surgeries annually. The trial faced no safety concerns.
Product Stage
growth-positive
Nano-Cap PolyPid's Lead Drug Candidate Cuts Surgical Infection Risk by 38% In Phase 3 Trial
PolyPid Ltd. announced positive topline results from its SHIELD II Phase 3 trial of D-PLEX100, aimed at preventing surgical site infections in patients undergoing abdominal colorectal surgery. The trial demonstrated a significant reduction in infection rates when D-PLEX100 was used alongside standard care, achieving both primary and secondary endpoints. The product uses Polymer-Lipid Encapsulation matriX technology for prolonged antibiotic release at the surgical site, showing promise in combating antibiotic-resistant bacteria. The trial involved patients from the United States, Europe, and Israel, and the results suggest a potential breakthrough in surgical infection prevention.
Product Stage
growth-positive
PolyPid to Host Conference Call and Webcast to Discuss D-PLEX₁₀₀ SHIELD II Phase 3 Trial Topline Results on Monday, June 9, 2025
PolyPid Ltd., a late-stage biopharma company, announced it will host a conference call to report topline data for its SHIELD II Phase 3 trial. The trial evaluates D-PLEX100 for preventing surgical site infections in abdominal colorectal surgery. PolyPids proprietary PLEX technology enables precise drug delivery, and its lead product candidate, D-PLEX100, is in Phase 3 clinical trials. The company is also testing OncoPLEX for treating solid tumors in preclinical stages. The announcement is seen as growth-positive, reflecting progress in their clinical trials.
Product Stage
growth-positive
Salesforce initiated, Dollar Tree upgraded: Wall Street’s top analyst calls
MongoDB received an upgrade from Monness Crespi to Buy from Neutral, with a new price target of $295. This decision follows MongoDBs Q1 performance, which exceeded expectations, and a positive outlook for Q2. The company also raised its fiscal 2026 guidance and announced an $800 million stock repurchase program, indicating strong financial health and confidence in future growth. These developments are seen as growth-positive for MongoDB, reflecting investor optimism and potential for stock appreciation.
Investment
growth-positive
PYPD: Assessing & Advancing Lead Candidate D-PLEX₁₀₀, Through Clinical Trials to Improve Surgical Outcomes, Enhance Treatment Efficacy, Minimize Side Effects
PolyPid Ltd., a late clinical stage biopharma company, is advancing its lead asset, D-PLEX100, through a pivotal Phase 3 clinical trial named SHIELD II. The trial aims to prevent surgical site infections in patients undergoing abdominal colorectal surgery. The company has successfully completed patient enrollment, with 800 participants across the U.S., Europe, and Israel. The independent Data Safety Monitoring Board recommended concluding enrollment early, suggesting positive efficacy signals. PolyPid plans to report top-line results by the end of Q2 2025 and intends to submit a New Drug Application to the FDA in early 2026, leveraging Fast Track and Breakthrough Therapy designations. The PLEX technology platform is designed for prolonged-release therapeutics, enhancing surgical outcomes and minimizing side effects.
Product StageFDA approved/pending approval
growth-positive
PolyPid to Participate in the Lytham Partners Spring 2025 Investor Conference on May 29, 2025
PolyPid Ltd., a late-stage biopharma company, is set to participate in the Lytham Partners Spring 2025 Investor Conference. The company will present a webcast and hold one-on-one meetings with investors. PolyPids lead product, D-PLEX100, is in Phase 3 clinical trials for preventing abdominal colorectal surgical site infections. Additionally, the company is in preclinical stages for OncoPLEX, targeting solid tumors like glioblastoma. The event aims to attract investor interest and support for PolyPids innovative drug delivery technology.
Product StageInvestment
growth-positive
PolyPid Ltd (PYPD) Q1 2025 Earnings Call Highlights: Strategic Advances Amid Financial Challenges
PolyPid Ltd has successfully completed enrollment for its Shield 2 phase 3 trial, marking a significant milestone. The company plans to submit a new drug application for Dplex 100 in early 2026, leveraging fast track and breakthrough therapy designations. PolyPid has secured $15 million in financing, extending its cash runway into Q3 2025. There is interest from potential US partners for Dplex 100, indicating strong commercial potential. However, the company reported a net loss of $8.3 million for Q1 2025, with increased R&D expenses. Pricing strategy for Dplex 100 is not finalized, and there are uncertainties regarding FDA inspection readiness and post-launch demand capacity.
Product StageInvestmentPartners
growth-positive
PolyPid Provides Corporate Update and Reports First Quarter 2025 Financial Results
PolyPid Ltd., a late-stage biopharma company, has successfully completed the enrollment of 800 patients in its Phase 3 SHIELD II trial for D-PLEX100, aimed at preventing abdominal colorectal surgical site infections. The company anticipates announcing top-line results by the end of Q2 2025, which could be transformative. PolyPid is preparing for regulatory submissions in 2026, leveraging its Fast Track and Breakthrough Therapy designations. The company is also advancing commercialization plans and engaging in partnership discussions in the U.S. Financially, PolyPid expects to generate an additional $27 million from warrant exercises upon announcing Phase 3 data, extending its financial runway beyond anticipated NDA approval.
Product StagePartnersInvestment
growth-positive
PolyPid to Report First Quarter 2025 Financial Results and Operational Highlights on May 14, 2025
PolyPid Ltd., a late-stage biopharma company, announced it will report its first quarter 2025 financial results on May 14, 2025. The company will host a conference call and webcast to discuss these results and provide updates on business operations. PolyPid is focused on improving surgical outcomes through its PLEX technology, which enables precise drug delivery. Its lead product, D-PLEX100, is in Phase 3 clinical trials for preventing surgical site infections. The company is also in preclinical stages for OncoPLEX, targeting solid tumors like glioblastoma.
Product Stage
growth-positive
PolyPid to Participate in The Citizens Life Sciences Conference
PolyPid Ltd., a late-stage biopharma company, announced its participation in the Citizens Life Sciences Conference in New York, scheduled for May 7-8, 2025. The company aims to improve surgical outcomes through its PLEX technology, which enables precise drug delivery. PolyPids lead product, D-PLEX100, is in Phase 3 clinical trials for preventing abdominal colorectal surgical site infections. Additionally, the company is in preclinical stages for OncoPLEX, targeting solid tumors like glioblastoma. During the conference, PolyPids management will engage in a fireside chat and one-on-one investor meetings, indicating a positive growth trajectory and potential investment opportunities.
Product StageInvestment
growth-positive
Q1 Virtual Investor Summit: On-Demand Presentations Now Live
The article discusses the presentations from the Q1 Investor Summit, highlighting various microcap companies and their developments. Alpha Tau Medical Ltd. is noted for achieving a 100% complete response rate in its recent U.S. trial results for skin cancer, indicating significant progress in its clinical trials. Other companies mentioned include Giftify, Inc., which is reaching profitability, and Vox Royalty Corp., which has shown substantial cash flow growth. The event provides a platform for investors to explore opportunities and insights from these companies, emphasizing their growth potential and market strategies.
Product Stage
growth-positive
PolyPid Announces Successful Completion of Enrollment in Phase 3 SHIELD II Trial of D-PLEX₁₀₀ for the Prevention of Abdominal Colorectal Surgical Site Infections
PolyPid Ltd., a late-stage biopharma company, has successfully completed enrollment in its SHIELD II Phase 3 trial for D-PLEX100, aimed at preventing surgical site infections in abdominal colorectal surgery patients. The trials enrollment was concluded following a positive recommendation from the Data Safety Monitoring Board. Top-line results are expected by the end of Q2 2025, and if positive, PolyPid plans to submit a New Drug Application to the FDA, leveraging its Fast Track and Breakthrough Therapy designations. The company is also in discussions with potential partners for the commercialization of D-PLEX100, particularly in the U.S.
Product Stage
growth-positive
PolyPid to Participate in the 37th Annual ROTH Conference
PolyPid Ltd., a late-stage biopharma company, announced its participation in the 37th Annual ROTH Conference in Dana Point, California, from March 17-18, 2025. The company will present its proprietary PLEX technology, which enables precise drug delivery, and its lead product candidate, D-PLEX100, currently in Phase 3 clinical trials for preventing surgical site infections. PolyPid is also in preclinical stages for OncoPLEX, targeting solid tumors. The conference will feature a fireside chat and one-on-one investor meetings, highlighting PolyPids growth potential and ongoing developments.
Product StageInvestment
growth-positive
PolyPid Ltd (PYPD) Q4 2024 Earnings Call Highlights: Strategic Advances Amid Rising R&D Costs
PolyPid Ltd has received a favorable recommendation from the Independent Data Safety Monitoring Board to conclude its Shield 2 phase 3 trial for D-PLEX100, indicating positive efficacy signals. The company secured $14.5 million in gross proceeds from a private placement financing, extending its cash runway into the third quarter of 2025. PolyPid anticipates submitting a new drug application for D-PLEX100, leveraging fast track and breakthrough therapy designations. The company is actively discussing partnerships for the commercialization of D-PLEX100, which has a significant market potential in the US. Despite reporting a net loss of $8.5 million for Q4 2024, the company is focused on finding a strong partner to aid in the commercialization process.
Product StageInvestmentPartners
growth-positive
PolyPid Provides Corporate Update and Reports Fourth Quarter and Full-Year 2024 Financial Results
PolyPid Ltd. has received a positive recommendation from the Data Safety Monitoring Board (DSMB) to continue its Phase 3 SHIELD II trial of D-PLEX100, aiming to enroll 800 patients. The trial has already enrolled over 700 patients, with completion expected by March 2025 and top-line results anticipated in the second quarter of 2025. The company completed a private placement financing of $14.5 million, with potential additional proceeds of $27 million from warrant exercises. This financing extends PolyPids cash runway beyond the expected NDA approval. PolyPid also announced a collaboration with ImmunoGenesis, Inc. and appointed Mr. Yitzchak Jacobovitz to its Board of Directors.
Product StageInvestmentPartnersManagement Changes
growth-positive
PolyPid to Participate in the Oppenheimer 35th Annual Healthcare Life Sciences Conference
PolyPid Ltd., a late-stage biopharma company, announced its participation in the Oppenheimer 35th Annual Healthcare Life Sciences Conference on February 11-12, 2025. The company will present its advancements, including its lead product candidate D-PLEX100, which is in Phase 3 clinical trials for preventing surgical site infections. PolyPid will also engage in one-on-one investor meetings, highlighting its proprietary PLEX technology that enables precise drug delivery. The event is seen as a positive opportunity for PolyPid to showcase its progress and attract potential investors.
Product StageInvestment
Neutral
PolyPid to Report Fourth Quarter and Full-Year 2024 Financial Results and Operational Highlights on February 12, 2025
PolyPid Ltd., a late-stage biopharma company, announced that it will report its fourth quarter and full-year 2024 financial results on February 12, 2025. The company will host a conference call and webcast to discuss the results and provide updates on business operations. PolyPid is focused on improving surgical outcomes through its PLEX technology, which enables precise drug delivery. Its lead product, D-PLEX100, is in Phase 3 clinical trials for preventing surgical site infections. The company is also testing OncoPLEX in preclinical stages for treating solid tumors. The announcement is primarily informational, detailing upcoming financial disclosures and ongoing clinical developments.
growth-positive
PolyPid 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 Million
PolyPid Ltd., a biopharma company, announced progress in its SHIELD II Phase 3 trial for D-PLEX100, aimed at preventing surgical site infections. The Data Safety Monitoring Board (DSMB) recommended concluding the study upon enrolling 800 patients, indicating positive efficacy signals. With 630 patients enrolled, the company expects to complete enrollment in Q1 2025 and report top-line results in Q2 2025. PolyPid plans to submit a New Drug Application (NDA) under Fast Track and Breakthrough Therapy designations, previously granted by the FDA. The financing and exercise of a Data-Triggered Warrant are expected to extend the cash runway beyond potential NDA approval. The company is also expediting partnership discussions globally.
InvestmentPartners
growth-positive
PolyPid Eyes Results From D-PLEX100 Trial in Q2 After Independent Board Gives Nod to Complete Enrollment
PolyPid announced that it expects to complete patient enrollment for its late-stage trial of D-PLEX100 by the second quarter of the following year. This development follows the approval from an independent board, which is a positive step for the company as it moves forward with its clinical trial. The completion of enrollment is crucial for advancing the trial and potentially bringing the product to market, which could significantly impact PolyPids growth prospects.
growth-positive
PolyPid announces research, development collaboration with ImmunoGenesis
PolyPid announced a research and development collaboration with ImmunoGenesis, a biotechnology company focused on immunotherapies. The collaboration aims to develop new formulations using PolyPids PLEX Technology and ImmunoGenesis STING agonist drug candidate to potentially improve treatments for solid tumors. This partnership is seen as a growth-positive move for PolyPid, leveraging its proprietary technology in a promising area of cancer treatment. The announcement comes amid PolyPids ongoing challenges with Nasdaq non-compliance and recent financial results, including a reported Q3 EPS of ($1.22) against a consensus of ($1.00).
Partners
growth-positive
PolyPid Announces Research and Development Collaboration with ImmunoGenesis Leveraging PLEX Technology to Enhance Cancer Immunotherapy
PolyPid Ltd., a late-stage biopharma company, announced a research and development collaboration with ImmunoGenesis, a clinical-stage biotechnology company. This partnership aims to develop novel formulations using PolyPids PLEX Technology and ImmunoGenesis STING agonist drug candidate to enhance treatment for solid tumors. The collaboration seeks to address challenges in drug delivery, particularly the rapid clearance of STING agonists, by leveraging PolyPids controlled and prolonged intratumoral drug delivery technology. This strategic partnership is expected to create innovative solutions in the field of immuno-oncology, potentially improving patient outcomes. PolyPid continues to explore additional opportunities for value creation through such collaborations.
Partners
growth-negative
PolyPid Announces Receipt of Nasdaq Notification of Minimum Stockholders’ Equity Non-Compliance
PolyPid Ltd., a biopharma company, has received a notification from Nasdaq indicating non-compliance with the minimum stockholders equity requirement for continued listing. The company reported equity of approximately $2,158,000, below the $2,500,000 threshold. PolyPid has until January 9, 2025, to submit a compliance plan. The companys shares will continue trading on Nasdaq during this period. PolyPids ongoing SHIELD II Phase 3 trial results are expected in December 2024, which could potentially secure additional funding of $18.5 million and $6.1 million from private placements if the trial shows positive efficacy. The company aims to regain compliance by exercising warrants from these placements.
InvestmentPublic Trading
growth-negative
PolyPid Ltd (PYPD) Q3 2024 Earnings Call Highlights: Strategic Advances Amid Financial Challenges
PolyPid Ltd has made progress in its Shield 2 pivotal trial with 550 subjects enrolled and 60 centers open globally. The company is financially stable, with funding secured beyond the interim analysis into 2026, contingent on warrant exercises. Despite positive results from the Shield 1 trial, PolyPid reported a net loss of $7.8 million for Q3 2024, up from $5.6 million in 2023, due to increased R&D expenses. The company is in discussions with strategic partners for the commercialization of DPLEX 100. However, there is uncertainty regarding the Shield 2 trials interim analysis outcome, which could affect its continuation. PolyPid faces risks related to the trials potential futility, though management remains optimistic.
InvestmentPartners
growth-positive
PolyPid Provides Corporate Update and Reports Third Quarter 2024 Financial Results
PolyPid Ltd., a late-stage biopharma company, announced the enrollment of the last patient required for the planned unblinded interim analysis in its ongoing SHIELD II Phase 3 trial of D-PLEX100. This trial aims to prevent abdominal colorectal surgical site infections. The interim analysis, expected later this quarter, could lead to early trial conclusion due to positive efficacy or continuation with further recruitment. The trial has enrolled over 540 patients across 60 centers in multiple countries. The SHIELD I trial results, published in the International Journal of Surgery, showed a significant reduction in surgical site infections in patients with large incisions. The SHIELD II study focuses on this subgroup, following FDA guidance. Enrollment completion is expected by December 2024, with top-line results anticipated in early 2025.
growth-positive
PolyPid to Participate in the Craig-Hallum 15th Annual Alpha Select Conference
PolyPid Ltd., a late-stage biopharma company, announced its participation in investor meetings at the Craig-Hallum 15th Annual Alpha Select Conference on November 19, 2024, in New York. The company focuses on improving surgical outcomes through its PLEX technology, which enables precise drug delivery. PolyPids lead product, D-PLEX100, is in Phase 3 clinical trials for preventing surgical site infections, and it is also exploring OncoPLEX for treating solid tumors. The participation in the conference is a strategic move to engage with potential investors and showcase its innovative solutions.
Investment
growth-positive
PolyPid to Report Third Quarter 2024 Financial Results and Operational Highlights on November 13, 2024
PolyPid Ltd., a late-stage biopharma company, announced it will release its third quarter 2024 financial results and operational highlights on November 13, 2024. The company will host a conference call and webcast to discuss these results and provide updates on its business operations. PolyPid focuses on improving surgical outcomes through its proprietary PLEX technology, which enables precise drug delivery over extended periods. Its lead product, D-PLEX100, is in Phase 3 clinical trials for preventing surgical site infections, while OncoPLEX is in preclinical stages for treating solid tumors. The announcement is seen as growth-positive, highlighting ongoing clinical trials and technological advancements.
growth-positive
PolyPid Announces Publication in International Journal of Surgery Highlighting Results of Phase 3 SHIELD I Trial of D-PLEX₁₀₀ in Prevention of Surgical Site Infections in Abdominal Colorectal Surgery
PolyPid Ltd., a late-stage biopharma company, announced the publication of results from its Phase 3 SHIELD I trial in the International Journal of Surgery. The trial evaluated the efficacy of D-PLEX100 in preventing surgical site infections (SSIs) in abdominal colorectal surgery. Although the primary endpoint was not met due to COVID-19-related challenges, subgroup analyses showed promising results, particularly in patients with incisions over 20 cm. The ongoing SHIELD II trial aims to further assess D-PLEX100s efficacy in patients with large surgical incisions, with top-line results expected in Q1 2025. The publication highlights the potential of D-PLEX100 as a future component of surgical care bundles, addressing the significant unmet need for SSI prevention.
growth-positive
PolyPid Announces Last Patient In for Planned Unblinded Interim Analysis in the Ongoing SHIELD II Phase 3 Trial Evaluating D-PLEX₁₀₀ for the Prevention of Abdominal Colorectal Surgical Site Infections
PolyPid Ltd., a late-stage biopharma company, announced the completion of patient enrollment for an unblinded interim analysis in its SHIELD II Phase 3 trial for D-PLEX100, aimed at preventing surgical site infections in abdominal colorectal surgeries. The interim analysis will be conducted this quarter, potentially leading to early trial conclusion, continued recruitment, or futility. The company has secured potential additional funding of $18.5 million and $6.1 million from January and August private placements, respectively, contingent on positive interim results and warrant exercises. Top-line results are anticipated in Q1 2025.
Investment
growth-positive
PolyPid to Participate in Three Upcoming Fall Investor Conferences
PolyPid Ltd., a late-stage biopharma company, announced its participation in three upcoming investor conferences: H.C. Wainwright 26th Annual Global Investment Conference, Lytham Partners Fall 2024 Investor Conference, and Sidoti & Company Micro-Cap Virtual Conference. The company will present its advancements, including its lead product candidate D-PLEX100, which is in Phase 3 clinical trials for preventing abdominal colorectal surgical site infections. PolyPids proprietary PLEX technology enables precise drug delivery over extended periods. The management team will also engage in one-on-one investor meetings during these events.
Investment
growth-positive
PolyPid Provides Corporate Update and Reports Second Quarter 2024 Financial Results
PolyPid Ltd., a late-stage biopharma company, has enrolled approximately 320 patients in its ongoing SHIELD II Phase 3 trial of D-PLEX100 for the prevention of abdominal colorectal surgical site infections. The company recently raised up to $14 million in financing, extending its cash runway into Q2 2025. PolyPid has also restructured its existing secured loan agreement with Kreos Capital VI (Expert Fund) LP, deferring over $2 million of repayments to be paid from April 2025 onwards. The company also promoted Ms. Dalit Hazan to Deputy Chief Executive Officer.
InvestmentManagement Changes
growth-positive
PolyPid Announces Private Placement for Up to $14 Million in Gross Proceeds
PolyPid Ltd., a late-stage biopharma company, has announced a securities purchase agreement for a private placement financing (PIPE) for $8.1 million in gross proceeds. The PIPE syndicate includes both new and existing investors. The company intends to use the net proceeds for its ongoing SHIELD II phase 3 clinical trial for the prevention of surgical site infections in patients undergoing abdominal colorectal surgery, working capital, and general corporate purposes. The company has also restructured its existing secured loan agreement with Kreos Capital VI (Expert Fund) LP with over $2 million of deferred repayments.
Investment
Neutral
PolyPid to Report Second Quarter 2024 Financial Results and Operational Highlights on August 14, 2024
PolyPid Ltd., a late-stage biopharma company, announced that it will report its second quarter 2024 financial results and operational highlights on August 14, 2024. The company will host a conference call and webcast to discuss the results and provide an update on business operations. PolyPids lead product candidate D-PLEX100 is in Phase 3 clinical trial for the prevention of abdominal colorectal surgical site infections. The company is also in preclinical stages to test the efficacy of OncoPLEX for the treatment of solid tumors, beginning with glioblastoma.
None
growth-positive
PolyPid Hosts KOL Call to Discuss Significant Unmet Medical Need in Surgical Site Infections Prevention and Provides Update on its Ongoing SHIELD II Phase 3 Trial
PolyPid Ltd., a late-stage biopharma company, has reported an increase in Surgical Site Infection (SSI) rates, signaling a return to pre-COVID levels. The company is currently conducting a SHIELD II Phase 3 trial for D-PLEX100, a product designed to prevent SSIs. The trial has enrolled approximately 250 patients of a planned total of 600 subjects. Top-line results are expected in the first quarter of 2025. The company also discussed the significant unmet medical need in the prevention of SSIs and the impact of patient risk factors on the development of SSIs.
CustomersManagement Changes
growth-positive
PolyPid to Host Virtual KOL Event on June 17, 2024, and Provide an Update on the Company’s Ongoing D-PLEX₁₀₀ Phase 3 Trial
PolyPid Ltd., a late-stage biopharma company, announced that it will host a virtual Key Opinion Leader event on June 17, 2024, to discuss the significant unmet medical need in surgical site infections and provide an update on the companys ongoing D-PLEX100 Phase 3 trial. The event will feature Charles E. Edmiston, Ph.D., Emeritus Professor of Surgery, Medical College of Wisconsin, who will discuss the clinical and economic burden of surgical site infections. PolyPids lead product candidate, D-PLEX100, will also be highlighted during the event.
Management Changes
growth-positive
PolyPid Ltd. (NASDAQ:PYPD) Q1 2024 Earnings Call Transcript
PolyPid Ltd. has released its Q1 2024 financial results, revealing substantial momentum in its business, particularly in its ongoing SHIELD II pivotal trial for D-PLEX100. The company has enrolled over 200 subjects in the trial, with 50 centers open in multiple countries. The company has also recently fortified its balance sheet, with a private placement financing in January 2024 raising $16 million. If the interim analysis of the SHIELD II trial is positive, the company could secure an additional $19 million. The companys cash runway now extends into Q4 2024.
InvestmentExpand
growth-positive
PolyPid Provides Corporate Update and Reports First Quarter 2024 Financial Results
PolyPid Ltd., a late-stage biopharma company, has enrolled over 200 patients in its ongoing SHIELD II Phase 3 trial of D-PLEX100 for the prevention of abdominal colorectal surgical site infections. The company has also closed a private placement financing for $16 million, extending its cash runway into Q4 2024. If the results of the unblinded interim analysis are positive and all of the warrants issued in the PIPE are exercised, PolyPid could secure an additional $19 million. The company reported a net loss of $6.4 million for Q1 2024.
Investment
Growth-Positive
PolyPid to Participate in Citizens JMP Life Sciences Conference
PolyPid Ltd., a late-stage biopharma company, announced that its management will present at the Citizens JMP Life Sciences Conference in New York from May 13 – 14, 2024. The management team will also participate in one-on-one investor meetings during this event. PolyPid is known for its proprietary PLEX technology that enables precise delivery of drugs at optimal release rates over durations ranging from several days to months. The companys lead product candidate D-PLEX100 is in Phase 3 clinical trial for the prevention of abdominal colorectal surgical site infections.
Management Changes
growth-positive
PolyPid Announces Enrollment of 200th Patient in Ongoing SHIELD II Phase 3 Trial Evaluating D-PLEX₁₀₀ for the Prevention of Abdominal Colorectal Surgical Site Infections
PolyPid Ltd., a late-stage biopharma company, has announced the enrollment of 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. 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. The company also announced that it has successfully completed a $16 million financing earlier this year and has the potential to secure an additional $19 million if the results of the unblinded interim analysis are positive and warrants are exercised.
Investment
growth-positive
PolyPid Announces Enrollment of 200th Patient in Ongoing SHIELD II Phase 3 Trial Evaluating D-PLEX₁₀₀ for the Prevention of Abdominal Colorectal Surgical Site Infections
PolyPid Ltd., a late-stage biopharma company, has announced the enrollment of the 200th patient in its SHIELD II Phase 3 trial for D-PLEX100, a drug aimed at preventing surgical site infections in patients undergoing abdominal colorectal surgery. The study is now approximately one-third enrolled and is expected to continue enrollment at a pace of 1.5 patients per center per month. The company also announced that it has successfully completed a $16 million financing earlier this year, which extends its cash runway beyond the anticipated timing of the study’s planned unblinded interim analysis. PolyPid has the potential to secure an additional $19 million if the results of the unblinded interim analysis are positive and warrants are exercised.
Investment
Growth-Positive
PolyPid to Report First Quarter 2024 Financial Results and Operational Highlights on May 8, 2024
PolyPid Ltd., a late-stage biopharma company, announced that it will report its first quarter 2024 financial results and operational highlights before the U.S. financial markets open on Wednesday, May 8, 2024. The company will host a conference call and webcast at 8:30 AM Eastern Time to discuss the results and provide an update on business operations. PolyPids lead product candidate D-PLEX100 is in Phase 3 clinical trial for the prevention of abdominal colorectal surgical site infections.
Public Trading
growth-positive
PYPD: Polypid is Enhancing Surgical Outcomes
PolyPid, a global late clinical-stage biopharma company, is making significant progress in its SHIELD II Phase 3 trial, which is investigating the efficacy of D-PLEX100 in preventing surgical site infections (SSIs). The company has enrolled over 100 patients and plans to conduct an interim analysis once about 400 patients have completed their 30-day follow-up, expected by mid-2024. In financial updates, PolyPid announced a net loss of $6.4 million for Q4 2023, and $23.9 million for the full year of 2023. However, the company secured $16 million in gross proceeds through a private placement financing in January 2024, extending its cash runway through late third quarter 2024.
InvestmentExpand
Growth-Positive
PolyPid to Participate in Barclays 26th Annual Global Healthcare Conference
PolyPid Ltd., a late-stage biopharma company, announced that its management will participate in a fireside chat at the Barclays 26th Annual Global Healthcare Conference in Miami Beach, FL, from March 12 – 14, 2024. The management team will also participate in one-on-one investor meetings during this event. PolyPid is known for its proprietary PLEX technology that enables precise delivery of drugs at optimal release rates over durations ranging from several days to months. The companys lead product candidate D-PLEX100 is in Phase 3 clinical trial for the prevention of abdominal colorectal surgical site infections.
Management Changes
growth-positive
PolyPid Ltd. (PYPD) Upgraded to Buy: What Does It Mean for the Stock?
PolyPid Ltd. has been upgraded to a Zacks Rank #2 (Buy) due to an upward trend in earnings estimates. The Zacks rating is determined by a companys changing earnings picture. The upgrade reflects positivity about PolyPids earnings outlook that could translate into buying pressure and an increase in its stock price. The company is expected to earn -$3.72 per share for the fiscal year ending December 2024, which represents a year-over-year change of 78%. Over the past three months, the Zacks Consensus Estimate for the company has increased 12.9%.
growth-positive
PolyPid Ltd. (PYPD) Upgraded to Buy: What Does It Mean for the Stock?
PolyPid Ltd. (PYPD) has been upgraded to a Zacks Rank #2 (Buy), reflecting a positive trend in earnings estimates. This upgrade indicates optimism about the companys earnings outlook, which could lead to increased buying pressure and a higher stock price. The Zacks rating system, which tracks earnings estimate revisions, has a strong track record of predicting near-term stock movements. Analysts have raised their earnings estimates for PolyPid Ltd. by 12.9% over the past three months, suggesting an improvement in the companys underlying business. This positions PolyPid Ltd. in the top 20% of Zacks-covered stocks, making it a solid candidate for market-beating returns.
growth-negative
PolyPid Ltd. (NASDAQ:PYPD) Q4 2023 Earnings Call Transcript
PolyPid Ltd. reported its Q4 2023 earnings, missing expectations with a reported EPS of $-3.97, compared to expected $-2.17. The company also discussed the progress of its SHIELD II trial for D-PLEX100 and the potential of OncoPLEX in oncology. PolyPid recently completed a $16 million financing round with participation from multiple new U.S. life sciences-focused investors. The company expects the initial $16 million to extend its cash runway until late in the third quarter of 2024. If the results of the unblinded interim analysis are positive and all warrants issued in the financing are exercised, the additional $19 million would fund PolyPid to the start of the planned new drug application submission for D-PLEX100.
InvestmentManagement Changes
growth-positive
PolyPid Provides Corporate Update and Reports Fourth Quarter and Full Year 2023 Financial Results
PolyPid Ltd., a late-stage biopharma company, has announced that it has enrolled over 100 patients in its ongoing SHIELD II Phase 3 trial for D-PLEX100, a treatment for the prevention of abdominal colorectal surgical site infections. The company also revealed new preclinical data showing that OncoPLEX, when injected intratumorally, reduced tumor volume and improved survival in new animal models. Additionally, PolyPid has raised $16 million in financing, extending its cash runway through late Q3 2024. The company could secure an additional $19 million if all warrants issued in the recent financing are exercised.
Investment
growth-positive
PolyPid Provides Corporate Update and Reports Fourth Quarter and Full Year 2023 Financial Results
PolyPid Ltd., a late-stage biopharma company, announced significant progress in its SHIELD II Phase 3 trial for D-PLEX100, aimed at preventing abdominal colorectal surgical site infections. Over 100 patients have been enrolled, with top-line results expected in the second half of 2024. The company also reported promising preclinical data for OncoPLEX, which showed reduced tumor growth and improved survival in animal models. PolyPid recently secured $16 million in financing, extending its cash runway through late Q3 2024, with potential for an additional $19 million if warrants are exercised. Financial results for 2023 showed reduced losses compared to 2022.
Investment
growth-positive
PolyPid Announces Enrollment of the 100th Patient in the Ongoing SHIELD II Phase 3 Trial
PolyPid Ltd., a late-stage biopharma company, has announced the enrollment and randomization of the 100th patient in its ongoing SHIELD II Phase 3 trial for D-PLEX100, a drug intended to prevent surgical site infections. The company recently closed a private placement financing for $16 million, with the potential to secure an additional $19 million if the results of an unblinded interim analysis are positive and all warrants issued in the recent financing are exercised. This would fund PolyPid to the start of a planned New Drug Application submission for D-PLEX100. Top-line results from the trial are expected in the second half of 2024.
Investment
Neutral
PolyPid to Report Fourth Quarter and Full-Year 2023 Financial Results and Operational Highlights on February 14, 2024
PolyPid Ltd., a late-stage biopharma company, has announced that it will report its Q4 and full-year 2023 financial results and operational highlights on February 14, 2024. The company will host a conference call and webcast to discuss the results and provide an update on business operations. PolyPids lead product candidate D-PLEX100 is in Phase 3 clinical trial for the prevention of abdominal colorectal surgical site infections. The company is also in preclinical stages to test the efficacy of OncoPLEX for the treatment of solid tumors, starting with glioblastoma.
Growth-Positive
PolyPid Announces Private Placement for $16 Million in Gross Proceeds
PolyPid Ltd., a late-stage biopharma company, has announced a securities purchase agreement for a private placement financing of $16.2 million. The financing was led by DAFNA Capital Management and Rosalind Advisors, among other investors. The proceeds will be used for the ongoing SHIELD II phase 3 clinical trial for the prevention of surgical site infections in patients undergoing abdominal colorectal surgery, working capital, and general corporate purposes. The private placement is expected to close on January 9, 2024.
Investment
growth-positive
PolyPid Announces Private Placement for $16 Million in Gross Proceeds
PolyPid Ltd., a late-stage biopharma company, has announced a private placement financing agreement for $16.2 million. The financing was led by U.S. life sciences-focused investors, including DAFNA Capital Management and Rosalind Advisors. The funds will be used for the companys ongoing SHIELD II phase 3 clinical trial for the prevention of surgical site infections in patients undergoing abdominal colorectal surgery, working capital, and general corporate purposes. The private placement is expected to close on January 9, 2024.
Investment
growth-positive
PolyPid Ltd. (NASDAQ:PYPD) Q3 2023 Earnings Call Transcript
PolyPid Ltd. held its Q3 2023 earnings call, discussing its financial results and ongoing clinical trials. The company reported no material impact on its operations or its SHIELD II trial due to recent violence in Israel. The company expects to have 40 centers open by the end of 2023 and top-line results from the trial are expected in the second half of 2024. The company also announced the appointment of Dr. Nurit Tweezer-Zaks to its Board of Directors. As of September 30, 2023, the company had cash and short-term deposits of $10.2 million and expects this to fund operations into late Q1 2024.
Management ChangesExpand
growth-positive
PolyPid Ltd. (NASDAQ:PYPD) Q3 2023 Earnings Call Transcript
PolyPid Ltd. held its Q3 2023 earnings call on November 12, 2023, discussing the progress of its SHIELD II pivotal trial for D-PLEX100, aimed at preventing surgical site infections. Despite recent violence in Israel, the company reported no material impact on operations. PolyPid plans to open 40 centers by the end of 2023 and expects top-line results in the second half of 2024. The company highlighted its regulatory pathway for D-PLEX100 in the U.S. and EU, recent manufacturing milestones, and cost containment efforts. Additionally, PolyPid welcomed Dr. Nurit Tweezer-Zaks to its Board of Directors and reported a net loss reduction compared to the previous year.
CustomersManagement ChangesExpand
growth-positive
PolyPid Provides Corporate Update and Reports Third Quarter 2023 Financial Results
PolyPid Ltd., a late-stage biopharma company, has provided a corporate update and reported financial results for the three and nine months ended September 30, 2023. The company has opened 20 centers for the ongoing SHIELD II Phase 3 trial and expects to open approximately 40 centers by the end of 2023. The company also announced the completion of three process validation batches of D-PLEX100 and a successful Good Manufacturing Practice audit. The company reported a net loss of $5.6 million for the three months ended September 30, 2023, compared to a net loss of $9.3 million for the same period in 2022. The company expects its current cash balance to fund operations into late first quarter of 2024.
Management ChangesInvestment
growth-positive
PolyPid Announces the Addition of Dr. Nurit Tweezer-Zaks to its Board of Directors
PolyPid Ltd., a late-stage biopharma company, has announced the appointment of Nurit Tweezer-Zaks, M.D., M.B.A, to its Board of Directors, effective November 6, 2023. This follows 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 also an experienced sector investor and was a practicing physician for nearly 15 years. The company is looking forward to leveraging Dr. Tweezer-Zaks’ expertise as they approach critical clinical and regulatory milestones.
Management Changes
growth-positive
PolyPid Announces the Addition of Dr. Nurit Tweezer-Zaks to its Board of Directors
PolyPid Ltd., a late-stage biopharma company, has announced the appointment of Nurit Tweezer-Zaks, M.D., M.B.A, to its Board of Directors, effective November 6, 2023. This follows 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 also an experienced sector investor and was a practicing physician for nearly 15 years. The company is looking forward to leveraging Dr. Tweezer-Zaks’ vast expertise as they approach critical clinical and regulatory milestones.
Management Changes
growth-positive
PolyPid to Report Third Quarter 2023 Financial Results and Operational Highlights on November 8, 2023
PolyPid Ltd., a late-stage biopharma company, announced that it will report its third quarter 2023 financial results and operational highlights on November 8, 2023. The company will host a conference call and webcast to discuss the results and provide an update on business operations. PolyPids lead product candidate D-PLEX100 is in Phase 3 clinical trial for the prevention of abdominal colorectal surgical site infections. The company is also in preclinical stages to test the efficacy of OncoPLEX for the treatment of solid tumors, beginning with glioblastoma.
Public Trading
growth-positive
PolyPid Regains Compliance with Nasdaq Minimum Closing Bid Price Rule
PolyPid Ltd., a late-stage biopharma company, has regained compliance with the Nasdaqs minimum bid price requirement for continued listing. The Nasdaq staff made this determination after the closing bid price of the companys ordinary shares was at $1.00 per share or greater for 11 consecutive business days. PolyPids lead product candidate D-PLEX100 is in Phase 3 clinical trial for the prevention of abdominal colorectal surgical site infections. The company is also in preclinical stages to test the efficacy of OncoPLEX for the treatment of solid tumors, beginning with glioblastoma.
Public Trading
growth-positive
PolyPid Announces Presentation at the American College of Surgeons Clinical Congress 2023
PolyPid Ltd., a late-stage biopharma company, announced that its SHIELD I Phase 3 clinical data for D-PLEX100 will be presented at the American College of Surgeons Clinical Congress 2023. The presentation will highlight the impact of the locally applied Doxycycline-Eluting Drug (D-PLEX) on incisional infection rate in elective colorectal surgery. The companys lead product candidate, D-PLEX100, is in Phase 3 clinical trial for the prevention of abdominal colorectal surgical site infections. PolyPid is also in preclinical stages to test the efficacy of OncoPLEX for the treatment of solid tumors, beginning with glioblastoma.
Customers
growth-positive
PolyPid Announces Publication of Preclinical Data Further Supporting the Good Safety Profile of D-PLEX₁₀₀ and PLEX Technology Platform
PolyPid Ltd., a late-stage biopharma company, has published positive preclinical results demonstrating the safety profile of D-PLEX100 and the PLEX technology platform in juvenile animals. The results could support further clinical evaluation of D-PLEX100 in a pediatric population. The safety and toxicokinetics of D-PLEX100 were tested following its administration via an abdominal incision to juvenile swine. No treatment-related adverse events were observed during this period. PolyPid’s ongoing Phase 3 SHIELD II trial of D-PLEX100 for the prevention of surgical site infections is currently recruiting patients undergoing open abdominal colorectal surgery with large incisions.
InvestmentExpand
Growth-Positive
PolyPid to Present at the 2023 Cantor Fitzgerald Global Healthcare Conference
PolyPid Ltd., a late-stage biopharma company, announced that its management will present at the Cantor Global Healthcare Conference in New York City from September 26-28, 2023. The company is known for its work on improving surgical outcomes through locally administered, controlled, prolonged-release therapeutics. Their lead product candidate, D-PLEX100, is currently in Phase 3 clinical trials for the prevention of abdominal colorectal surgical site infections. They are also in preclinical stages for the treatment of solid tumors, starting with glioblastoma.
Management Changes
growth-positive
PolyPid Announces Successful Commercial Good Manufacturing Practice (GMP) Audit by Israeli Ministry of Health
PolyPid Ltd., a late-stage biopharma company, has announced a successful Good Manufacturing Practice (GMP) audit of its manufacturing facility by the Israeli Ministry of Health. The audit found no critical or major findings and concluded that the facility, process, and quality system conform to current GMP requirements for medicinal products. This audit is also valid for Europe under the Agreement on Conformity Assessment and Acceptance of industrial products (ACAA) between the European Union and Israel. This milestone brings the company closer to the potential global commercialization of its lead product candidate, D-PLEX100.
Expand
growth-negative
PolyPid Announces Reverse Share Split
PolyPid Ltd., a late-stage biopharma company, has announced a reverse share split of its issued and outstanding ordinary shares at a ratio of 1-for-30. The move was approved by shareholders and the companys board of directors on September 18, 2023. The first date when the company’s ordinary shares will begin trading on the Nasdaq Capital Market on a post-reverse split basis is expected to be September 21, 2023. The company expects that the reverse share split will allow it to regain compliance with Nasdaq’s $1.00 minimum bid price requirement.
Public Trading
growth-positive
PolyPid Announces Successful Completion of Manufacturing Process Validation for D-PLEX₁₀₀
PolyPid Ltd., a late-stage biopharma company, has successfully completed the production of three process validation batches of D-PLEX100, a significant step towards the planned submission of D-PLEX100 New Drug Application (NDA) and Marketing Authorization Application (MAA) regulatory filings. This achievement is the result of a significant facility expansion and scale-up that more than tripled the company’s capacity to manufacture D-PLEX100 for the U.S., EU, and global markets. The companys ongoing Phase 3 SHIELD II trial of D-PLEX100 for the prevention of surgical site infections (SSIs) is currently recruiting patients.
CustomersExpand
growth-positive
PolyPid Provides Corporate Update and Reports Second Quarter 2023 Financial Results
PolyPid Ltd., a late-stage biopharma company, has reached an agreement with the U.S. FDA on the design of the SHIELD II Phase 3 trial for the prevention of abdominal colorectal surgical site infections. The company resumed recruitment for the trial in late June 2023 and expects to have 20 centers open in the U.S., Europe, and Israel by the end of the current quarter. The company also reported financial results for the three and six months ended June 30, 2023, highlighting cost containment efforts that have generated over $1 million in savings year-to-date.
CustomersInvestment
Neutral
PolyPid to Report Second Quarter 2023 Financial Results and Operational Highlights on August 9, 2023
PolyPid Ltd., a late-stage biopharma company, has announced that it will report its second quarter 2023 financial results and operational highlights before the U.S. financial markets open on Wednesday, August 9, 2023. The company will host a conference call and webcast at 8:30 AM Eastern Time to discuss the results and provide an update on business operations. PolyPids lead product candidate D-PLEX100 is in Phase 3 clinical trial for the prevention of abdominal colorectal surgical site infections.
Public Trading
growth-positive
PolyPid Announces New Publication Highlighting Potent Antibacterial Activity of D-PLEX₁₀₀ against Susceptible and Resistant Bacteria for the Prevention of Surgical Site Infections
PolyPid Ltd., a late-stage biopharma company, has announced the potent antibacterial activity of D-PLEX100, a prophylactic drug against bacteria causing surgical site infections (SSIs), including resistant strains. The data from pre-clinical and phase 2 clinical studies showed significant antibacterial activity of D-PLEX100. The drugs high antibacterial efficacy is due to its ability to support high local doxycycline concentration over a prolonged period in the surgical site. The efficacy and safety of D-PLEX100 are currently being evaluated in the SHIELD II Phase 3 clinical trial, with results expected in mid-2024.
Investment
growth-positive
PolyPid Announces Recruitment of First Patient in Revised SHIELD II Phase 3 Trial Evaluating D-PLEX₁₀₀ for Prevention of Abdominal Colorectal Surgical Site Infections
PolyPid Ltd., a late-stage biopharma company, has announced the recruitment of the first patient for its revised SHIELD II Phase 3 trial. The trial will evaluate D-PLEX100 for the prevention of abdominal colorectal surgical site infections (SSIs). The U.S. Food and Drug Administration (FDA) recently accepted the companys revised protocol for SHIELD II, which is recruiting patients undergoing colorectal resection surgery with large incisions. The trial is expected to enroll an estimated 550 additional patients and the top-line results are expected in mid-2024.
Customers
growth-positive
PolyPid Announces 180-Day Extension to Regain Compliance with Nasdaq Minimum Bid Requirement and Transfer of its Listing to the Nasdaq Capital Market
PolyPid Ltd., a late-stage biopharma company, has received an extension from Nasdaq to regain compliance with its minimum bid price rule and approval to transfer its ordinary shares from The Nasdaq Global Market to The Nasdaq Capital Market. The transfer will be effective from June 6, 2023. The company had previously received a letter from Nasdaq in December 2022, indicating that it was not in compliance with Nasdaq Listing Rule 5450(a)(1) due to its closing bid price being below $1.00 per share for 30 consecutive business days. With the transfer, Nasdaq has granted PolyPid an additional 180-day period to regain compliance.
Public Trading
growth-positive
PolyPid Announces FDA Agreement on the Design of SHIELD II Phase 3 Trial Evaluating D-PLEX₁₀₀ for Prevention of Abdominal Colorectal Surgical Site Infections
PolyPid Ltd., a late-stage biopharma company, announced that the U.S. Food and Drug Administration (FDA) has approved the companys SHIELD II Phase 3 trial design. The trial will evaluate D-PLEX100 for the prevention of abdominal colorectal surgical site infections (SSIs). The company plans to resume recruitment for the trial, with an estimated 550 additional patients beyond the 40 already recruited. The total recruitment time is expected to be approximately 12 months, with top-line results expected in mid-2024.
Expand
growth-negative
PolyPid Ltd. (NASDAQ:PYPD) Q1 2023 Earnings Call Transcript
PolyPid Ltd. reported its Q1 2023 earnings, missing expectations with a reported EPS of $-0.28, compared to the expected $-0.26. The company also discussed the progress of its SHIELD II Phase III trial and potential MAA and NDA submissions. PolyPid has also strengthened its balance sheet, with a recent underwritten public offering and a restructured loan agreement with Kreos Capital. The company is also seeking additional partners for D-PLEX100 and is focusing on PLEX platform-related collaborations. Management changes were also announced, with Yossi BenAmram joining as an independent Director and Jonny Missulawin being promoted to CFO.
Management Changes
growth-positive
PolyPid Provides Corporate Update and Reports First Quarter 2023 Financial Results
PolyPid Ltd., a late-stage biopharma company, has submitted a revised protocol for its SHIELD II Phase 3 trial to the FDA. The trial is expected to resume soon with the recruitment of an estimated 550 additional patients. The company has also completed a series of financial transactions to extend its cash runway into late Q1 2024. This includes a public offering and a private placement of pre-funded warrants with certain existing shareholders, raising approximately $11.4 million. It also restructured a loan agreement with Kreos Capital, deferring over $3 million of repayments. Additionally, Yossi BenAmram, former SVP and President of Merck & Co.’s Europe, Russia, Africa, and Middle East region, has been appointed to the companys board.
Management ChangesInvestment
growth-positive
Sidoti's Micro-Cap Virtual May Conference
Sidoti & Company, LLC has announced the schedule for its two-day May Micro-cap Conference taking place on May 10-11, 2023. The conference will feature presentations from a variety of small and microcap companies, including Polypid Ltd., HydroGraph Clean Power Inc., Orange Polska, AnPac Bio-Medical Science, InfuSystem Holdings Inc., and many others. The firm is a leading provider of independent securities research focused on small and microcap companies and the institutions that invest in their securities. The conference is part of Sidotis Company Sponsored Research program, which covers about 200 companies.
Customers
Growth-Positive
PolyPid to Report First Quarter 2023 Financial Results and Operational Highlights on May 10, 2023
PolyPid Ltd., a late-stage biopharma company, announced that it will report its first quarter 2023 financial results and operational highlights before the opening of the U.S. financial markets on Wednesday, May 10, 2023. The company will host a conference call and webcast at 8:30 AM Eastern Time to discuss the results and provide an update on business operations. PolyPids lead product candidate D-PLEX100 is in Phase 3 clinical trials for the prevention of soft tissue abdominal and sternal bone surgical site infections.
growth-positive
PolyPid to Participate in Upcoming Investor Conferences
PolyPid Ltd., a late-stage biopharma company, has announced that its management will participate in several upcoming investor conferences. These include the Aegis Capital Corp. Virtual Conference, the Sidoti & Company Micro-Cap Virtual Conference, and the JMP Securities Life Sciences Conference. The companys management team will also participate in one-on-one investor meetings during these events. PolyPid is currently working on improving surgical outcomes through its proprietary PLEX technology and is in Phase 3 clinical trials for its lead product candidate D-PLEX100.
Investment
growth-negative
PolyPid Announces Receipt of Nasdaq Notification of Minimum Stockholders’ Equity Non-Compliance
PolyPid Ltd., a late-stage biopharma company, has been notified by the Nasdaq Stock Market that it is no longer in compliance with the minimum stockholders equity requirement for continued listing on the Nasdaq Global Market. The companys stockholders’ equity was $5,829,000 as of December 31, 2022, falling short of the required $10,000,000. PolyPid has until May 25, 2023, to submit a plan to regain compliance. The company believes it will be able to demonstrate compliance due to its recent public offering and private placement, which raised approximately $11.4 million.
Public Trading
growth-positive
PolyPid Announces Closing of Underwritten Public Offering, Including Full Exercise of Overallotment Option, and Concurrent Private Placement with $11.4 Million in Aggregate Gross Proceeds
PolyPid Ltd., a late-stage biopharma company, has closed an underwritten public offering of ordinary shares, raising approximately $7.1 million. The company also closed a concurrent private placement of pre-funded warrants with certain existing shareholders, raising an additional $4.35 million. PolyPid has also restructured its existing secured loan agreement with Kreos Capital VI (Expert Fund) LP, deferring over $3 million of repayments. The funds will be used to support ongoing clinical activities, the development of D-PLEX100, working capital, and other general corporate purposes.
InvestmentPartners
growth-positive
PolyPid Announces Pricing of $6.2 Million Underwritten Public Offering of Ordinary Shares and Concurrent $4.4 Million Private Placement of Pre-Funded Warrants
PolyPid Ltd., a late-stage biopharma company, has announced the pricing of a public offering of 14,660,000 ordinary shares at $0.42 per share, expecting to raise approximately $6.2 million. The company has also granted the underwriter a 30-day option to purchase up to an additional 2,199,000 ordinary shares. Concurrently, PolyPid is entering into a private placement of pre-funded warrants to purchase up to 10,357,139 ordinary shares with certain existing shareholders, expecting to raise approximately $4.4 million. The proceeds will be used to fund ongoing clinical activities, development of D-PLEX100, and other corporate purposes. The transactions are expected to close on March 31, 2023.
InvestmentPublic Trading
growth-positive
PolyPid Announces Proposed Underwritten Public Offering of Ordinary Shares
PolyPid Ltd., a late-stage biopharma company, has announced the commencement of an underwritten public offering of its ordinary shares. The company also intends to grant the underwriter, Newbridge Securities Corporation, a 30-day option to purchase up to an additional 15% of the number of Ordinary Shares offered in the offering at the public offering price, less underwriting discounts and commissions. The net proceeds from the offering will be used to fund ongoing clinical activities and development of D-PLEX100, working capital, and other general corporate purposes.
Public TradingInvestment
Growth-Positive
PolyPid to Present at the Barclays Global Healthcare Conference
PolyPid Ltd., a late-stage biopharma company, has announced that it will present at the Barclays Global Healthcare Conference in Miami, Florida, from March 14-16, 2023. The company is known for its proprietary PLEX technology that enables precise delivery of drugs at optimal release rates over durations ranging from several days to months. PolyPids lead product candidate, D-PLEX100, is currently in Phase 3 clinical trials for the prevention of soft tissue abdominal surgical site infections. The company is also in preclinical stages to test the efficacy of OncoPLEX for the treatment of solid tumors, starting with glioblastoma.
Public Trading
growth-positive
PolyPid Ltd. (NASDAQ:PYPD) Q4 2022 Earnings Call Transcript
PolyPid Ltd. held its Q4 2022 earnings call on February 8, 2023. The company discussed its financial results for the 3 and 12 months ended December 31, 2022, and provided updates on its clinical program. The company is particularly excited about the potential NDA submissions for D-PLEX100 in the U.S. following a positive Type C meeting communication with the U.S. FDA. The company also discussed its plans for 2023, including interactions with European regulatory authorities, attracting additional partners, and entering collaborations. The company expects its current cash runway to extend well into the third quarter of this year.
Management Changes
growth-positive
PolyPid Provides Corporate Update and Reports Fourth Quarter and Full Year 2022 Financial Results
PolyPid Ltd., a late-stage biopharma company, has clarified its regulatory pathway for D-PLEX100, a drug aimed at preventing abdominal colorectal surgical site infections. Following a positive communication with the FDA, the company expects to resume patient recruitment in Q2 2023 for its ongoing SHIELD II trial. The trial will be enriched with approximately 550 additional patients to complete clinical testing for potential NDA. Top-line results from the SHIELD II trial are anticipated by mid-2024. The company also reported financial results for the three months and full year ended December 31, 2022.
InvestmentManagement Changes
Neutral
PolyPid to Report Fourth Quarter and Full Year 2022 Financial Results and Operational Highlights on February 8, 2023
PolyPid Ltd., a late-stage biopharma company, announced that it will report its Q4 and full year 2022 financial results and operational highlights on February 8, 2023. The company will host a conference call and webcast to discuss the results and provide an update on business operations. PolyPids lead product candidate D-PLEX100 is in Phase 3 clinical trials for the prevention of soft tissue abdominal surgical site infections. The company is also in preclinical stages to test the efficacy of OncoPLEX for the treatment of solid tumors, starting with glioblastoma.
Public Trading
growth-positive
PolyPid Provides Positive Regulatory Update for D-PLEX₁₀₀ for the Prevention of Surgical Site Infections in Abdominal Colorectal Surgery
PolyPid Ltd., a late-stage biopharma company, has provided a positive regulatory update for D-PLEX100, a product aimed at preventing abdominal colorectal surgical site infections. Following a recent interaction with the FDA, the company now has clarity regarding the regulatory pathway toward a potential New Drug Application (NDA) submission. 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 ongoing SHIELD II study, which has enrolled over 200 patients, could potentially serve as such a study.
Investment
growth-positive
PolyPid Announces Publication in the American Journal of Surgery of Phase 2 Clinical Trial Post-hoc Analysis for D-PLEX₁₀₀ in the Prevention of Surgical Site Infections in Abdominal Surgery
PolyPid Ltd., a late-stage biopharma company, has announced positive results from a Phase 2 trial of D-PLEX100, a drug designed to prevent surgical site infections (SSIs) in abdominal surgery. The trial showed a significant reduction in SSIs in patients with multiple preoperative risk factors. The study demonstrated a 53% statistically significant relative risk reduction of the SSI rate within 30 days post-surgery in the D-PLEX100 cohort compared to the standard of care. The results suggest that D-PLEX100 may be an effective addition to current SSI prevention measures in patients with increased risk for surgical complications.
Customers
growth-positive
PolyPid 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 Surgery | BioSpace
PolyPid Ltd., a late-stage biopharma company, has scheduled a Type D meeting with the U.S. Food and Drug Administration (FDA) in January 2023 to discuss the results of the SHIELD I Phase 3 study and regulatory requirements for the indication of D-PLEX100 for the prevention of abdominal colorectal surgical site infections. The company has already provided the FDA with the currently available data from the completed SHIELD I study. The CEO and Board Chairman of PolyPid have shown their confidence in the potential of D-PLEX100 by making significant open market stock purchases.
CustomersManagement Changes
growth-positive
PolyPid 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 Surgery
PolyPid Ltd., a late-stage biopharma company, has scheduled a Type D meeting with the U.S. Food and Drug Administration (FDA) for January 2023 to discuss the results of the SHIELD I Phase 3 study and regulatory requirements for D-PLEX100, a product designed to prevent surgical site infections (SSIs). The company has already provided the FDA with available data from the study. The CEO and Board Chairman have shown their confidence in the product by making significant open market stock purchases.
Customers
growth-negative
PolyPid Announces Receipt of Nasdaq Minimum Bid Price Notification
PolyPid Ltd., a late-stage biopharma company, has received a notice from Nasdaq indicating that it is not in compliance with the minimum bid price requirement for continued listing. The company has been granted a period of 180 calendar days to regain compliance with the minimum bid price requirement. If the company does not regain compliance after the initial 180-day period, it may be eligible for an additional 180-day 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.
Public Trading
growth-positive
PolyPid Announces Presentation of Phase 2 D-PLEX₁₀₀ Clinical Data at the First Triennial Meeting of the International Orthopaedic Trauma Association
PolyPid Ltd., a late-stage biopharma company, announced that Phase 2 clinical data for D-PLEX100 will be presented at the first triennial International Orthopaedic Trauma Association meeting on December 14-16, 2022. The presentation will highlight the products efficacy in preventing surgical wound infections, including those caused by multi-drug resistant organisms. The companys lead product candidate, D-PLEX100, is in Phase 3 clinical trials for the prevention of soft tissue abdominal and sternal bone surgical site infections.
Investment
growth-positive
PolyPid Announces Presentation of Phase 2 D-PLEX₁₀₀ Clinical Data at the First Triennial Meeting of the International Orthopaedic Trauma Association
PolyPid Ltd., a late-stage biopharma company, announced that Phase 2 clinical data for D-PLEX100 will be presented at the first triennial International Orthopaedic Trauma Association meeting in December 2022. The presentation will focus on the efficacy of D-PLEX100 in preventing surgical wound infections, including those caused by multi-drug resistant organisms. The companys lead product candidate, D-PLEX100, is currently in Phase 3 clinical trials for the prevention of soft tissue abdominal and sternal bone surgical site infections.
Customers
Growth-Positive
PolyPid Announces Eligibility for European Medicines Agency Centralized Procedure for D-PLEX₁₀₀ for the Prevention of Surgical Site Infections in Abdominal Surgery
PolyPid Ltd., a late-stage biopharma company, has received confirmation from the European Medicines Agency (EMA) that its lead product candidate, D-PLEX100, is eligible for submission of a Marketing Authorization Application (MAA) in the European Union (EU) under the Agency’s centralized procedure. This 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. D-PLEX100 is designed to provide local prolonged and controlled anti-bacterial activity directly at the surgical site to prevent Surgical Site Infections (SSIs).
CustomersExpand
growth-positive
PolyPid Announces Peer-Reviewed Publication of Phase 2 Clinical Trial Results for D-PLEX₁₀₀ in the Prevention of Surgical Site Infections in Abdominal Surgery
PolyPid Ltd., a late-stage biopharma company, has announced the publication of positive clinical data from the Phase 2 study of D-PLEX100 for the prevention of surgical site infections (SSIs) in abdominal surgery. The results showed a 64% statistically significant relative risk reduction in the D-PLEX100 plus standard of care cohort. The company plans to discuss the clinical outcomes and next steps for D-PLEX100 with the FDA and the EU regulatory authorities in Q1 2023. The companys second Phase 3 trial of D-PLEX100, SHIELD II, will be evaluated following the discussion with the FDA and the EU regulatory authorities.
Investment
PolyPid plunges 73% after trial disappointment
growth-positive
PolyPid Announces Exclusive Licensing Agreement with ADVANZ PHARMA for the Commercialization of D-PLEX₁₀₀ in Europe
PolyPid Ltd. has entered into an exclusive licensing agreement with ADVANZ PHARMA Corp. for the commercialization of its lead drug candidate, D-PLEX100, in Europe. The drug is designed to prevent surgical site infections in abdominal and cardiac surgeries. Under the terms of the agreement, PolyPid will receive an upfront payment and additional development-related milestones for a total of up to $23.5 million. Upon commercialization, PolyPid will receive up to $89 million in sales-related milestones. PolyPid will also supply D-PLEX100 to ADVANZ PHARMA for a transfer price and will be entitled to royalties on net sales.
PartnersInvestment
growth-positive
PolyPid Announces Planned CEO Transition
PolyPid Ltd., a Phase 3 biopharmaceutical company, has announced that its Board of Directors has appointed Dikla Czaczkes Akselbrad, currently the Company’s Executive Vice President and Chief Financial Officer, as PolyPid’s Chief Executive Officer, effective July 1, 2022. Amir Weisberg, who currently serves as Chief Executive Officer and a director, will retire from the Chief Executive Officer position, effective on July 1, 2022. The company also announced that Shaul Mukhtar, Chief Operating Officer of PolyPid, will be retiring from the Company, effective March 2022.
Management Changes
growth-positive
PolyPid Initiates First Phase 3 Clinical Trial of D-PLEX100 for the Prevention of Post-Abdominal Surgery Incisional Infections
PolyPid Ltd., a biopharmaceutical company, has announced the enrolment of the first patient in the SHIELD I trial, a Phase 3 clinical trial of its lead product candidate D-PLEX100, for the prevention of post-abdominal surgery incisional infection. The trial will assess the efficacy and safety of D-PLEX100 administered with the Standard of Care (SoC), compared to a SoC-treated control arm. The trial will enrol a minimum of 616 patients, with a maximum of about 900 patients, in approximately 50 centres in the United States, Europe and Israel.
Customers
growth-positive
PolyPid raises $60m at third IPO attempt
PolyPid, a Petah Tikva-based company that has developed an implant for delayed release of antibiotics, has successfully completed its IPO on Nasdaq, raising $60 million at a valuation of $272 million. The companys share price rose 18.75% to $19, giving the company a market cap of $323 million. This was the companys third attempt at a flotation. The main investors in PolyPid before the offering were Morris Kahns Aurum Ventures, CHealth Ventures, the Friendly Angels Club group, Shavit Capital, and Xenia Venture Capital. The company is currently in the midst of a Phase III trial aimed at obtaining US FDA approval for its product.
InvestmentPublic Trading
growth-positive
PolyPid Ltd. Announces Pricing of Initial Public Offering
PolyPid Ltd., a Phase 3 clinical-stage pharmaceutical company, has announced the pricing of its initial public offering (IPO) of 3,750,000 ordinary shares at $16.00 per share, for gross proceeds of $60.0 million. The shares are expected to begin trading on The Nasdaq Global Market under the symbol PYPD on June 26, 2020. The offering is expected to close on June 30, 2020. Barclays and BMO Capital Markets acted as joint book-running managers.
Public Trading
growth-positive
Polypid sets terms to raise $50m in Nasdaq IPO
Israeli therapeutics developer, Polypid, has set terms for its Nasdaq IPO, aiming to raise between $47-53 million at a company valuation of $246-278 million. This is the companys third attempt at an IPO, with previous attempts in 2014 and 2018 falling through due to market conditions. Polypid has developed an implant for the delayed release of antibiotics and is currently in the midst of a Phase III trial aimed at obtaining US FDA approval for its product.
Public TradingInvestment
growth-positive
PolyPid takes aim at Nasdaq once again
PolyPid, a company that has developed an implant for the delayed release of antibiotics, is planning an IPO at a valuation of $300 million. This will be the companys third attempt at an IPO, with previous attempts in 2014 and 2018 being postponed due to falling markets. The company is currently in the midst of a Phase III trial aimed at obtaining US FDA approval for its product. The main investors in PolyPid include Morris Kahns Aurum Ventures, CHealth Ventures, Leon Recantais GlenRock, the Friendly Angels Club group, Shavit Capital, Xenia Venture Capital, and private investors from the US.
Public TradingInvestment
Growth-Positive
PolyPid Announces the Initiation of a Phase 3 Clinical Trial of D-PLEX100 for the Prevention of Sternal Wound Infection Post-cardiac Surgery BioSpace
PolyPid Ltd., a Phase 3 clinical-stage biopharmaceutical company, has announced the enrollment of the first patient in a Phase 3 clinical trial for D-PLEX100, a product designed to prevent surgical site infections (SSIs). The trial, called SHIELD, will evaluate D-PLEX100 plus the standard of care versus the standard of care only for the prevention of sternal wound infection post-cardiac surgery. The trial will enroll a minimum of 1,284 subjects, with a maximum of about 1,600 subjects, in approximately 45 centers in the U.S., Europe, and Israel.
CustomersExpand
growth-positive
Drug developer PolyPid to file for Wall Street IPO
Drug development company PolyPid is planning to file a confidential draft prospectus with the US Securities and Exchange Commission (SEC) for an IPO. This comes two years after the company withdrew its Nasdaq IPO due to market conditions. PolyPid has raised $105 million to date, including $50 million in a private financing round six months ago. The companys product is an antibiotic packed in a polymer and lipid matrix, which releases the antibiotic in a measured dosage over a period of time.
Public TradingInvestment
growth-positive
PolyPid Announces Positive Top-line Results from Phase 2 Clinical Trial of D-PLEX100 for the Prevention of Surgical Site Infections in Abdominal Surgery
PolyPid Ltd., a biopharmaceutical company, has announced positive results from its Phase 2 clinical trial of D-PLEX100 for the prevention of surgical site infections (SSI) in abdominal surgery. The trial showed a significant decrease in SSIs of 57 percent, compared to the standard of care alone. The company now plans to hold an end of Phase 2 meeting with the FDA and subsequently submit an IND to conduct a Phase 3 clinical trial in abdominal surgery.
Investment
growth-positive
Drug development co PolyPid raises $50m
Israeli drug development company PolyPid Ltd. has closed a $50 million Series E-1 preferred shares financing round. The financing was led by existing institutional shareholders and included US-based high-net worth investors. The company plans to use the proceeds to advance the clinical development of its lead product D-PLEX into two phase III pivotal registration trials. PolyPid had previously sought to raise $75 million on Nasdaq last year at a company valuation of $370 million but pulled the IPO due to adverse market conditions.
Investment
PolyPid gets a second QIDP designation for D-PLEX100
growth-positive
PolyPid Announces FDA Clearance of Investigational New Drug Application (IND) to Commence Pivotal Phase 3 Clinical Trial of D-PLEX[100] for the Prevention of Sternal Wound Infection Post-Cardiac Surgery
PolyPid Ltd., a clinical-stage biopharmaceutical company, has received approval from the United States Food and Drug Administration (FDA) to proceed with its phase 3 clinical trial of its lead asset D-PLEX[100] for the prevention of post-cardiac surgery sternal infections. The clinical trial is expected to start in the first half of 2019. The IND clearance of the Pivotal Phase 3 clinical trial by the FDA is a significant regulatory milestone for the company and its lead D-PLEX[100] program.
InvestmentExpand
Growth-Positive
Biotech Company Polypid Raises $15 Million
Israel-based biotech company Polypid Ltd. has raised $15 million from both shareholders and new investors. The investment was made according to a pre-funding company valuation of $180 million. Polypid develops encapsulating drug delivery technology that enables extended and localized release in the body of tricky compounds. The companys initial focus is on post-surgical site infections. In March, the company postponed its planned initial public offering on Nasdaq due to a slump that occurred following President Donald Trump’s decision to impose tariffs on $50 billion worth of Chinese goods.
InvestmentPublic Trading
growth-positive
Drug release co PolyPid sets terms for $75m Nasdaq IPO
Israeli drug release developer PolyPid is set to go public on Nasdaq. The company, which develops delayed release drugs for preventing post-operative infections in cardiac surgery and compound fracture cases, is looking to raise $75 million at a company value of $370 million. The IPO is scheduled for March 23. The companys previous investors are expected to spend $20 million on buying shares in the offering. The main shareholders are Morris Kahns Aurum Ventures, Shavit Capital, Xenia Venture Capital Ltd., and Eitan Kyiet, Haim Hurvitz, and Leon Recanati.
InvestmentPublic Trading
growth-positive
Israeli co PolyPid files for $86m Nasdaq IPO
Israeli therapeutics company PolyPid Ltd. has filed a prospectus to raise $86 million on Nasdaq. The company, which focuses on antibiotics for the prevention and treatment of post-surgical site infections, did not disclose a company value but market sources estimate it at $300-400 million after money. Goldman Sachs, Cowen & Company and Cantor Fitzgerald are the joint bookrunners on the deal. The company first filed in October 2014 to raise $20 million in an IPO at a company value of $80 million but withdrew the prospectus in 2015 and in 2016 received a private investment of $22 million instead.
InvestmentPublic Trading
growth-positive
FDA fast tracks Israeli co PolyPid
Israeli company PolyPid Optimized Therapeutics has been accepted into the US Food and Drug Administration (FDA) Qualified Infectious Disease Program (QIDP). The company is developing a localized delayed release antibiotic for the treatment of bone infections. The QIDP status will give the company preference in the FDA testing process and five years of exclusivity in the market. The product is about to enter Phase III trials for prevention of post cardiac surgery sternal infections. PolyPid also announced positive interim results from a trial of another product, BonyPid, a synthetic bone substitute that releases antibiotics.
InvestmentExpand
growth-positive
Drug release co PolyPid raises $5.3m
PolyPid Optimized Therapeutics, a drug company in which Xenia Venture Capital holds an 8.4% stake, has raised $5.3 million in a financing round. The round reflected a $104 million value for PolyPid, giving Xenias holding a value of NIS 33 million following the round. PolyPid has developed technology that combines polymers and fatty acids to create a system for delayed release of drugs. Its leading product is a delayed release antibiotic for preventing bone infections. The company has recruited former Compugen CFO Dikla Czaczkes Akselbrad as chief strategy officer, indicating that it plans to renew its plans for an IPO.
InvestmentManagement Changes
growth-positive
Israeli drug development co Polypid raises $22m
Israeli pharmaceutical company Polypid Ltd. has raised $22 million in a Series D financing round. The funding was led by new investor Shavit Capital and current investor Aurum Ventures. The investment will be used to complete a European clinical trial for BonyPid-1000, a synthetic bone substitute, and to finance the initiation of a phase III clinical study for D-PLEX, a product designed to prevent post-cardiac surgery infections. Polypid CEO Amir Weisberg said the investment will help the company advance its pipeline towards commercialization.
InvestmentManagement Changes
Growth-Positive
PolyPid Announces First Patient Enrolled in Confirmatory Clinical Trial, Evaluating Performance and Safety of BonyPid-1000™, an Antibiotic Eluting Bone Void Filler
PolyPid Ltd., a specialty pharmaceutical company, has announced the enrollment of the first patient in the clinical trial of BonyPid-1000, a doxycycline loaded synthetic bone substitute. The trial will be conducted on 64 patients with severe open tibia fractures at eight sites in Israel and Asia. The primary aim of the study is to determine the performance and safety of BonyPid-1000 on bone healing in traumatic open fracture patients over a period of six and 12 months, compared with standard care.
Customers
growth-positive
PolyPid revives planned Nasdaq IPO
Orthopedic pharmaceutical company PolyPid is reviving its plans for a Nasdaq IPO, with a new prospectus for raising $18-22 million at an $80 million company value. The company has developed a delayed-release drug for treatment of compound bone fractures, which is scheduled to enter clinical trials in 2015. The company hopes to enter the European market by 2017. This offering is likely to be the first by an Israeli biomedical company in 2015.
InvestmentPublic Trading
growth-positive
PolyPid sets terms for $20m Nasdaq IPO
Orthopedic drug developer PolyPid Ltd. has set terms for its Nasdaq IPO. The company plans to raise $20 million by offering 1.8 million shares at a price range of $10 to $12. This would give the company a value of more than $100 million after money. The IPO is being led by Aegis underwriters together with MLV and Chardan Capital. PolyPid has developed an implant that facilitates regular delayed release of drugs into the bones. The company is scheduled to begin clinical trials in the US and Europe in 2015.
InvestmentPublic Trading
PolyPid Team
Employee Info
| Employees (range) | 51-200 |
| Exact count | 68 |
| Team members | 5 |
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PolyPid Internal
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Admin Info
| Confidence | 91/100 |
| Missing | markets, not claimed |
| BI Verification | Yanina Wainscheinker |
| Registrar ID | 514105923 |
| Crunchbase | polypid |
| Phone | +972747195700 |
| Creator | Rebecca Mack |
| Creator email | rebeccamack26@gmail.com |
| Last updater | Matan Eblagon |
| Updater email | matane@sncentral.org |
| Last update | 2024-05-05T00:00:00.000Z |
| Created | 2014-07-28T00:00:00.000Z |
| Claimed | Yes |
| Status detail | Public on NASDAQ on Jun, 2020; |