PYPD PolyPid Ltd.

8.17
+0.94  (+13%)
Previous Close 7.23
Open 7.42
52 Week Low 6.9716
52 Week High 16.5
Market Cap $153,241,177
Shares 18,756,570
Float 15,682,034
Enterprise Value $86,338,001
Volume 47,502
Av. Daily Volume 31,265
Stock charts supplied by TradingView

Upcoming Catalysts

Drug Stage Catalyst Date
D-PLEX100 - SHIELD I
Abdominal (soft tissue) sternal surgical site infections
Phase 3
Phase 3
Premium membership is required to view catalyst dates, analyst ratings, earnings dates and cash burn data. Click here to unlock and sign up to a 14-day FREE TRIAL.
D-PLEX100 (SHIELD II)
Surgical Site Infection
Phase 3
Phase 3
Lorem ipsum dolor sit amet, consectetur adipiscing elit. Quisque sapien.

Drug Pipeline

Drug Stage Notes
D-PLEX100
Sternal (bone) sternal surgical site infections
Phase 3
Phase 3
Phase 3 trial initiated December 2019. Enrolment paused due to COVID-19.

Latest News

  1. PETAH TIKVA, Israel, July 28, 2021 (GLOBE NEWSWIRE) -- PolyPid Ltd. (NASDAQ:PYPD), a late-stage biopharma company aiming to improve surgical outcomes through locally administered, controlled, extended-release therapeutics, today announced that it will report its second quarter 2021 financial results and operational highlights before the open of the U.S. financial markets on Wednesday, August 11, 2021. 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.

    Conference Call Dial-In & Webcast Information:

    Date: Wednesday, August 11, 2021
    Time:8:30 AM Eastern Time
    United States:+1 877 870 9135
    Israel:+972 1809 213-985
    International:+44 (0) 2071 928338
    Conference

    PETAH TIKVA, Israel, July 28, 2021 (GLOBE NEWSWIRE) -- PolyPid Ltd. (NASDAQ:PYPD), a late-stage biopharma company aiming to improve surgical outcomes through locally administered, controlled, extended-release therapeutics, today announced that it will report its second quarter 2021 financial results and operational highlights before the open of the U.S. financial markets on Wednesday, August 11, 2021. 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.

    Conference Call Dial-In & Webcast Information:

    Date: Wednesday, August 11, 2021
    Time:8:30 AM Eastern Time
    United States:+1 877 870 9135
    Israel:+972 1809 213-985
    International:+44 (0) 2071 928338
    Conference ID:1663949
    Webcast:https://edge.media-server.com/mmc/p/2eu7k7nj

    About PolyPid

    PolyPid Ltd. (NASDAQ:PYPD) is a late-stage biopharma company aiming to improve surgical outcomes through locally administered, controlled, extended-release therapeutics. PolyPid's proprietary PLEX (Polymer-Lipid Encapsulation matriX) technology pairs with medications, enables precise delivery of drugs at effective release rates, over durations ranging from several days to months. PolyPid's lead product candidate D-PLEX100 is in Phase 3 clinical trials for the prevention of sternal and abdominal surgical site infections (SSIs).

    For additional company information, please visit http://www.polypid.com and follow us on Twitter and LinkedIn.

    Forward-looking Statements

    This press release contains projections and other forward-looking statements regarding future events or our future financial performance. All statements other than present and historical facts and conditions contained in this release are forward-looking statements (within the meaning of the Private Securities Litigation Reform Act of 1995, Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended). These statements are only predictions and reflect our current beliefs and expectations with respect to future events and are based on assumptions and subject to risk and uncertainties and subject to change at any time. Actual events or results may differ materially from those contained in the projections or forward-looking statements. Forward-looking statements in this release are made pursuant to the safe harbor provisions contained in the Private Securities Litigation Reform Act of 1995. References and links to websites have been provided as a convenience, and the information contained on such websites is not incorporated by reference into this press release. PolyPid is not responsible for the contents of third-party websites.

    Contacts: 

    PolyPid, Ltd. 

    Dikla Czaczkes Akselbrad

    EVP & CFO

    Tel: +972-747195700

    Investors:

    Bob Yedid

    LifeSci Advisors

    646-597-6989

    Media Contact:

    Nechama Feuerstein

    551-444-0784



    Primary Logo

    View Full Article Hide Full Article
  2. TEL AVIV, Israel and RADNOR, Pa., July 12, 2021 /PRNewswire/ -- NRx Pharmaceuticals (NASDAQ:NRXP), a clinical stage pharmaceutical company announced today that it has signed a Memorandum Of Understanding with the Government of Israel to license exclusive worldwide development, manufacturing, and marketing rights to a novel Coronavirus vaccine developed by the Israel Institute for Biological Research (IIBR).

    The BriLife™ vaccine (technical name VSV ΔG1) is based on a previous, FDA-approved vaccine platform that was further optimized by IIBR and targeted towards COVID-19. Because BriLife™ is a self-propagating, live-virus vaccine, NRx anticipates rapid and affordable industrial scaleup and manufacturing. The vaccine will initially be delivered by traditional injection. 

    The initiative will be led by NRx Chairman and CEO Jonathan Javitt, together with NRx Director Chaim Hurvitz, who chairs CH Health, an Israeli Private Equity group.

    "We at NRx are honored to have been selected by the Government of Israel to carry forward this life-saving mission," said Mr. Hurvitz.  As the first generation COVID vaccines are increasingly challenged by rapid mutation of the Coronavirus, we aim to develop a vaccine that can rapidly scale at low cost to serve the needs of both the developed and the developing world."

    "As a physician and public health professional, I am inspired by the privilege of collaborating with an institution whose scientific roots date to Jonas Salk and the fight against Polio," said Prof Jonathan C Javitt, MD, MPH, CEO and Chairman of NRx, who has been involved in the fight against Coronaviruses since the 2002 SARS epidemic. "In its first year, the COVID pandemic has killed four million people worldwide, constituting the worst public health catastrophe since the 1918 Influenza epidemic. As the virus mutates and challenges the immunity we have built through first-generation vaccines, we are excited to expand our focus on COVID by including a vaccine platform that has potential to scale at high speed and low cost."

    In its collaboration with NRx, the IIBR will provide technical assistance, while receiving customary royalty and milestone payments for its intellectual property.  NRx has further committed to supplying all required doses of the vaccine for the population of Israel.

    About NRx Pharmaceuticals

    NRx (www.nrxpharma.com) draws upon more than 300 years of collective, scientific and drug-development experience to bring improved health to patients. Its investigational product, ZYESAMI™ (aviptadil) for patients with COVID-19, has been granted Fast Track designation by the US Food and Drug Administration, (FDA) and is currently undergoing phase 3 trials funded by the US National Institutes of Health, the Biomedical Advanced Research and Development Authority (BARDA) of the US Department of Health and Human Services, and the Medical Countermeasures program of the US Department of Defense. The FDA has additionally granted Breakthrough Therapy Designation and a Special Protocol Agreement to NRx for NRX-101, an investigational medicine to treat suicidal bipolar depression. NRX-101 is currently in Phase 3 trials, with readouts expected in 2022.

    NRx is led by executives who have held senior roles at Allergan, J&J, Lilly, Novartis, Pfizer, and the US FDA. NRx is chaired by Prof. Jonathan Javitt, MD, MPH (Adj. Professor, Johns Hopkins School of Medicine), who serves as a Senior Fellow in the National Security Health Policy Center of the Potomac Institute for Policy Studies. In addition to 30 years of experience in drug development, Dr. Javitt has been appointed to leadership roles under Presidents Reagan, Bush ('41), Clinton, and Bush ('43), where he served as a Special Employee of the Undersecretary of Defense. The NRx board includes Dr. Sherry Glied, former US Assistant Secretary for Health (ASPE), Daniel E. Troy, JD, former Chief Counsel of the US FDA, Chaim Hurvitz, former director of Teva and President of the Teva International Group, and General HR McMaster, Ph.D. (US Army, Ret.) the 26th United States National Security Advisor. NRx is publicly traded on the Nasdaq Global Select Exchange under the stock ticker NRXP.

    About CH Health

    CH Health is a Tel Aviv-based private equity group that has played a key role in the founding and advancement of a series of pharmaceutical companies including Kite Pharmaceuticals (Nasdaq:KITE, now owned by Gilead Sciences (Nasdaq: GILD), Urogen (NASDAQ:URGN), Polypide (NASDAQ:PYPD), Galmed (NASDAQ:GLMD), and NRx (NASDAQ:NRXP). CH Health is led by Mr. Chaim Hurvitz, former director of Teva Pharmaceuticals (NASDAQ:TEVA) and former President of the Teva International Group, where he led global development and sales of Copaxone throughout its life cycle. Mr. Hurvitz is a graduate in political science from Tel Aviv University and serves as President of the pharmaceutical section of the Israel Manufacturer's Organization. As Chairman of the Tel-Aviv Yafo Foundation, he plays an active philanthropic role in the community.

    About the Israel Institute for Biological Research

    The IIBR is a center for research and development in the fields of biology, chemistry and the environment. Its mission is to strengthen the capabilities and resilience of the State of Israel. The scientists at IIBR have accumulated extensive knowledge and expertise over the decades in areas including: the development and implementation of advanced methods for detection and identification, research of disease processes, planning and development of vaccines and diverse therapeutic methods and more. The institute employs hundreds of scientists, some of them leaders in their fields in Israel and around the world.  They work in laboratories and biotechnological facilities that enable the development and production of advanced products and vaccines, under strict regulatory conditions.

    Cautionary Note Regarding Forward-Looking Statements

    This announcement of NRx Pharmaceuticals, Inc. includes "forward-looking statements" within the meaning of the "safe harbor" provisions of the U.S. Private Securities Litigation Reform Act of 1995, which may include, but are not limited to, statements regarding our financial outlook, product development, business prospects, and market and industry trends and conditions, as well as the company's strategies, plans, objectives, and goals. These forward-looking statements are based on current beliefs, expectations, estimates, forecasts, and projections of, as well as assumptions made by, and information currently available to, the company's management.   

    The company assumes no obligation to revise any forward-looking statement, whether as a result of new information, future events or otherwise.    Accordingly, you should not place reliance on any forward-looking statement, and all forward-looking statements are herein qualified by reference to the cautionary statements set forth above. 

    1 Pronounced "VSV delta G"

    CORPORATE CONTACT                                                      

    INVESTOR RELATIONS





    Jack Hirschfield                                                                                  

    John Mullaly

    Head of Corporate Communications, NRx                             

    LifeSci Advisors

                                                     

    512-674-5163                                                                                     

    617-429-3548

     

    Cision View original content to download multimedia:https://www.prnewswire.com/news-releases/nrx-pharmaceuticals-announces-partnership-with-the-israel-institute-for-biological-research-to-complete-development-and-commercialization-of-brilife-covid-vaccine-301331618.html

    SOURCE NRx Pharmaceuticals

    View Full Article Hide Full Article
  3. PETAH TIKVA, Israel, July 12, 2021 (GLOBE NEWSWIRE) -- PolyPid Ltd. (NASDAQ:PYPD), a late-stage biopharma company focusing on developing targeted, locally administered and prolonged-release therapeutics to improve surgical outcomes, today announced that it has appointed leading colorectal surgeon Anthony J. Senagore, M.D., as its Senior Medical Director.

    In his position, Dr. Senagore will be responsible for developing PolyPid's medical infrastructure in the United States, and will contribute to the Company's NDA submission, approval and commercial launch of its lead product candidate, D-PLEX100, a novel drug product candidate designed to prevent surgical site infections (SSIs) by providing local prolonged and controlled anti-bacterial activity…

    PETAH TIKVA, Israel, July 12, 2021 (GLOBE NEWSWIRE) -- PolyPid Ltd. (NASDAQ:PYPD), a late-stage biopharma company focusing on developing targeted, locally administered and prolonged-release therapeutics to improve surgical outcomes, today announced that it has appointed leading colorectal surgeon Anthony J. Senagore, M.D., as its Senior Medical Director.

    In his position, Dr. Senagore will be responsible for developing PolyPid's medical infrastructure in the United States, and will contribute to the Company's NDA submission, approval and commercial launch of its lead product candidate, D-PLEX100, a novel drug product candidate designed to prevent surgical site infections (SSIs) by providing local prolonged and controlled anti-bacterial activity directly at the surgical site.

    "I am delighted to welcome Dr. Senagore to the PolyPid team as we continue to advance toward commercialization of D-PLEX100," stated Amir Weisberg, CEO of PolyPid. "With near-term clinical and regulatory milestones ahead, Dr. Senagore's experience as a practicing surgeon and biopharmaceutical innovator, as well as his unique understanding of the budgeting process of hospital systems, will prove invaluable to our pursuit to reduce the clinical and financial burden of surgical site infections."

    Anthony J. Senagore, M.D., is a colorectal surgeon with a long track record of academic surgery practice and significant experience in healthcare start-up companies. He has served as Professor of Surgery at several prestigious academic medical centers, including University of Texas Medical Branch at Galveston, Central Michigan University College of Medicine, the University of Southern California, Keck School of Medicine, Cleveland Clinic Foundation, and Spectrum Health/Michigan State University. Dr. Senagore has experience with payment policy and health care economics with service on the AMA/CMA Relative Value Update Committee for 16 years and as Chair of the Practicing Physicians Advisory Committee for the Centers for Medicaid Services. In addition, Dr. Senagore has edited five textbooks in colon and rectal surgery and authored over 230 peer-reviewed publications and 25 textbook chapters.

    Commenting on his appointment, Dr. Senagore said, "Despite advancements in health technologies, SSIs remain the most prevalent type of surgery related healthcare acquired infection, burdening our economy and reducing the quality of care. I am thrilled to join PolyPid and help lead the company toward its goal of preventing the risk of SSIs to protect patients, facilitate the recovery journey, and alleviate unnecessary healthcare costs."

    About PolyPid

    PolyPid Ltd. (NASDAQ:PYPD) is a Phase 3 biopharmaceutical company aiming to improve surgical outcomes through locally administered, controlled, extended-release therapeutics. PolyPid's proprietary PLEX (Polymer-Lipid Encapsulation matriX) technology pairs with medications, enables precise delivery of drugs at effective release rates, over durations ranging from several days to months. PolyPid's lead product candidate D-PLEX100 is in Phase 3 clinical trials for the prevention of sternal and abdominal surgical site infections (SSIs).

    For additional company information, please visit http://www.polypid.com and follow us on Twitter and LinkedIn.

    About Dr. Anthony J. Senagore

    Anthony J. Senagore, M.D., is a colorectal surgeon with a long record of academic surgery practice. In his previous roles, Dr. Senagore served as the Chief Strategy Officer for Genetesis, a privately-held medical technology company, and consulted for several healthcare start-up companies. He has also served as Professor of Surgery at several prestigious academic medical centers, including the University of Texas Medical Branch at Galveston, Central Michigan University College of Medicine, University of Southern California's Keck School of Medicine, Michigan State University's Spectrum Health and the Cleveland Clinic Foundation. Dr. Senagore has served as Chair of the Colorectal Surgery Residency Review Committee for the Accreditation Council for Graduate Medical Education, President of the Board of Colon and Rectal Surgery. Dr. Senagore is the past President of the American Society of Colon and Rectal Surgeons and Midwest Surgical Association. He also served on the Relative Value Update Committee for 16 years and as Chair of the Practicing Physicians Advisory Committee for the Centers for Medicaid Services. Dr. Senagore has significant experience in revenue cycle and capacity management for healthcare. In addition, during his career, he was involved in the development of many innovations in laparoscopic colorectal surgery and the field of enhanced recovery. Dr. Senagore earned his medical degree from Michigan State University (MSU), East Lansing, MI. He completed his residency in General Surgery at the Butterworth Hospital/MSU program. Dr. Senagore then completed a research fellowship and colon and rectal surgery residency at Ferguson Hospital on the Grand Rapids and East Lansing campuses of MSU. He later received his Master of Science degree in physiology from MSU and a Master of Business Administration from the University of Phoenix, San Francisco, CA campus. Dr. Senagore has edited five textbooks in colon and rectal surgery and authored over 230 peer-reviewed publications and 25 textbook chapters.

    Forward-looking Statements

    This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act and other securities laws. Words such as "expects," "anticipates," "intends," "plans," "believes," "seeks," "estimates" and similar expressions or variations of such words are intended to identify forward-looking statements. For example, the Company is using forward-looking statements when it discusses its ongoing clinical trials and plans. Forward-looking statements are not historical facts, and are based upon management's current expectations, beliefs and projections, many of which, by their nature, are inherently uncertain. Such expectations, beliefs and projections are expressed in good faith. However, there can be no assurance that management's expectations, beliefs and projections will be achieved, and actual results may differ materially from what is expressed in or indicated by the forward-looking statements. Forward-looking statements are subject to risks and uncertainties that could cause actual performance or results to differ materially from those expressed in the forward-looking statements. For a more detailed description of the risks and uncertainties affecting the Company, reference is made to the Company's reports filed from time to time with the Securities and Exchange Commission ("SEC"), including, but not limited to, the risks detailed in the Company's Annual Report on Form 20-F filed on March 5, 2021. Forward-looking statements speak only as of the date the statements are made. The Company assumes no obligation to update forward-looking statements to reflect actual results, subsequent events or circumstances, changes in assumptions or changes in other factors affecting forward-looking information except to the extent required by applicable securities laws. If the Company does update one or more forward-looking statements, no inference should be drawn that the Company will make additional updates with respect thereto or with respect to other forward-looking statements.

    References and links to websites have been provided as a convenience, and the information contained on such websites is not incorporated by reference into this press release. PolyPid is not responsible for the contents of third-party websites.

    Corporate Contact

    PolyPid, Ltd.

    Dikla Czaczkes Akselbrad

    EVP & CFO

    Tel: +972-747195700

    Investor Contact

    Bob Yedid

    LifeSci Advisors

    646-597-6989

    Media Contact

    Nechama Feuerstein

    551-444-0784

     



    Primary Logo

    View Full Article Hide Full Article
  4. PETAH TIKVA, Israel, June 23, 2021 (GLOBE NEWSWIRE) -- PolyPid Ltd. (NASDAQ:PYPD), a late-stage biopharma company aiming to improve surgical outcomes through locally administered, controlled, extended-release therapeutics, announced that Dikla Czaczkes Akselbrad, Executive Vice President and Chief Financial Officer will present today at The Raymond James Human Health Innovation Conference at 9:20 am EDT.

    The presentation will be webcast live and archived 90 days on PolyPid's Investor Relations website, which can be found at: https://investors.polypid.com/events-and-presentations/events.

    About PolyPid

    PolyPid Ltd. (NASDAQ:PYPD) is a late-stage biopharma company aiming to improve surgical outcomes through locally administered, controlled…

    PETAH TIKVA, Israel, June 23, 2021 (GLOBE NEWSWIRE) -- PolyPid Ltd. (NASDAQ:PYPD), a late-stage biopharma company aiming to improve surgical outcomes through locally administered, controlled, extended-release therapeutics, announced that Dikla Czaczkes Akselbrad, Executive Vice President and Chief Financial Officer will present today at The Raymond James Human Health Innovation Conference at 9:20 am EDT.

    The presentation will be webcast live and archived 90 days on PolyPid's Investor Relations website, which can be found at: https://investors.polypid.com/events-and-presentations/events.

    About PolyPid

    PolyPid Ltd. (NASDAQ:PYPD) is a late-stage biopharma company aiming to improve surgical outcomes through locally administered, controlled, extended-release therapeutics. PolyPid's proprietary PLEX (Polymer-Lipid Encapsulation matriX) technology pairs with medications, enables precise delivery of drugs at effective release rates, over durations ranging from several days to months. PolyPid's lead product candidate D-PLEX100 is in Phase 3 clinical trials for the prevention of sternal and abdominal surgical site infections (SSIs).

    For additional company information, please visit http://www.polypid.com and follow us on Twitter and LinkedIn.

    Forward-looking Statements

    This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act and other securities laws. Words such as "expects," "anticipates," "intends," "plans," "believes," "seeks," "estimates" and similar expressions or variations of such words are intended to identify forward-looking statements. For example, the Company is using forward-looking statements when it discusses its ongoing clinical trials, plans to use the guidance provided by the FDA to progress with its SHIELD I program, the timing of top-line results of the SHIELD I trial, and the size and design of the SHIELD I trial. Forward-looking statements are not historical facts, and are based upon management's current expectations, beliefs and projections, many of which, by their nature, are inherently uncertain. Such expectations, beliefs and projections are expressed in good faith. However, there can be no assurance that management's expectations, beliefs and projections will be achieved, and actual results may differ materially from what is expressed in or indicated by the forward-looking statements. Forward-looking statements are subject to risks and uncertainties that could cause actual performance or results to differ materially from those expressed in the forward-looking statements. For a more detailed description of the risks and uncertainties affecting the Company, reference is made to the Company's reports filed from time to time with the Securities and Exchange Commission ("SEC"), including, but not limited to, the risks detailed in the Company's Annual Report on Form 20-F filed on March 5, 2021. Forward-looking statements speak only as of the date the statements are made. The Company assumes no obligation to update forward-looking statements to reflect actual results, subsequent events or circumstances, changes in assumptions or changes in other factors affecting forward-looking information except to the extent required by applicable securities laws. If the Company does update one or more forward-looking statements, no inference should be drawn that the Company will make additional updates with respect thereto or with respect to other forward-looking statements.

    References and links to websites have been provided as a convenience, and the information contained on such websites is not incorporated by reference into this press release. PolyPid is not responsible for the contents of third-party websites.

    Corporate Contact

    PolyPid, Ltd.

    Dikla Czaczkes Akselbrad

    EVP & CFO

    Tel: +972-747195700

    Investor Contact

    Bob Yedid

    LifeSci Advisors

    646-597-6989

    Media Contact

    Nechama Feuerstein

    551-444-0784



    Primary Logo

    View Full Article Hide Full Article
  5. FDA Agreed that a Single Pivotal Phase 3 Study is Sufficient for Potential Approval of D-PLEX100for the Prevention of Surgical Site Infections in Colorectal Surgery.

    • Enrollment in Phase 3 SHIELD I Trial of D-PLEX100 in Abdominal Surgery Continues to Advance; Over 200 Patients Enrolled to Date

    • Top-line Results Expected by Year-end

    PETAH TIKVA, Israel, May 19, 2021 (GLOBE NEWSWIRE) -- PolyPid Ltd. (NASDAQ:PYPD), a late-stage biopharma company aiming to improve surgical outcomes through locally administered, controlled, extended-release therapeutics, announced today it has received written responses from the U.S. Food and Drug Administration (FDA) to a Type B meeting request that the Company submitted regarding its development plan for D-PLEX…

    FDA Agreed that a Single Pivotal Phase 3 Study is Sufficient for Potential Approval of D-PLEX100 for the Prevention of Surgical Site Infections in Colorectal Surgery.

    • Enrollment in Phase 3 SHIELD I Trial of D-PLEX100 in Abdominal Surgery Continues to Advance; Over 200 Patients Enrolled to Date



    • Top-line Results Expected by Year-end

    PETAH TIKVA, Israel, May 19, 2021 (GLOBE NEWSWIRE) -- PolyPid Ltd. (NASDAQ:PYPD), a late-stage biopharma company aiming to improve surgical outcomes through locally administered, controlled, extended-release therapeutics, announced today it has received written responses from the U.S. Food and Drug Administration (FDA) to a Type B meeting request that the Company submitted regarding its development plan for D-PLEX100.

    The FDA indicated that PolyPid's proposal for a single Phase 3 pivotal study (SHIELD I), provided the study results are adequate, would provide sufficient evidence of clinical efficacy and safety to support approval of D-PLEX100 for the prevention of surgical site infections (SSIs) in colorectal surgery. The Type B meeting was requested following PolyPid's receipt of Breakthrough Therapy Designation from the FDA for D-PLEX100 for the prevention of SSIs in patients undergoing elective colorectal surgery.

    "We appreciate the thoughtful feedback from the FDA regarding our clinical program, and we are thrilled with the acceptance of our proposed development plan for the potential approval of D-PLEX100, which also reduces overall anticipated costs for the program," said Amir Weisberg, PolyPid's CEO. "PolyPid is dedicated to tackling the issue of SSIs that accounts for 20 percent of all healthcare-acquired infections in the U.S., resulting in extended hospital stays and readmission, costing up to $10 billion in annual medical costs. We will use the responses provided to progress our SHIELD I trial which continues to enroll patients at the expected rate, with over 200 patients enrolled to date, and we anticipate the availability of top-line results by the end of 2021."

    Launched in July 2020, SHIELD I is a prospective, multinational, multicenter, randomized, double blind Phase 3 trial designed to assess the efficacy and safety of D-PLEX100 for the prevention of incisional SSIs post-abdominal surgery. The primary endpoint of the trial is the combination of incisional SSIs and mortality rate as measured by the proportion of subjects with either an SSI event, as determined by a blinded and independent adjudication committee, or mortality for any reason within 30 days post-surgery. The trial will enroll a minimum of 616 patients, with a maximum of about 900 patients, as defined by the adaptive study design, in more than 60 centers in the United States, Europe and Israel.

    About D-PLEX100

    PolyPid's lead product candidate, D-PLEX100, is a novel drug product candidate designed to provide local prolonged and controlled anti-bacterial activity directly at the surgical site to prevent SSIs. Following the administration of D-PLEX100 into the surgical site, the PLEX technology enables a prolonged and constant release of the broad-spectrum antibiotic doxycycline, resulting in high local concentration of the drug for a period of four weeks for the prevention of SSIs, with additional potential to prevent SSIs caused by antibiotic-resistant bacteria at the surgical site. D-PLEX100 has received Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA) for the prevention of SSIs in patients undergoing elective colorectal surgery. D-PLEX100 has also received two Qualified Infectious Disease Product (QIDP) designations as well as two Fast Track designations for the prevention of post-abdominal surgery incisional infection and for the prevention of sternal wound infection post-cardiac surgery.

    About PolyPid

    PolyPid Ltd. (NASDAQ:PYPD) is a late-stage biopharma company aiming to improve surgical outcomes through locally administered, controlled, extended-release therapeutics. PolyPid's proprietary PLEX (Polymer-Lipid Encapsulation matriX) technology pairs with medications, enables precise delivery of drugs at effective release rates, over durations ranging from several days to months. PolyPid's lead product candidate D-PLEX100 is in Phase 3 clinical trials for the prevention of sternal and abdominal surgical site infections (SSIs).

    For additional company information, please visit http://www.polypid.com and follow us on Twitter and LinkedIn.

    Forward-looking Statements

    This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act and other securities laws. Words such as "expects," "anticipates," "intends," "plans," "believes," "seeks," "estimates" and similar expressions or variations of such words are intended to identify forward-looking statements. For example, the Company is using forward-looking statements when it discusses its ongoing clinical trials, plans to use the guidance provided by the FDA to progress with its SHIELD I program, the timing of top-line results of the SHIELD I trial, and the size and design of the SHIELD I trial. Forward-looking statements are not historical facts, and are based upon management's current expectations, beliefs and projections, many of which, by their nature, are inherently uncertain. Such expectations, beliefs and projections are expressed in good faith. However, there can be no assurance that management's expectations, beliefs and projections will be achieved, and actual results may differ materially from what is expressed in or indicated by the forward-looking statements. Forward-looking statements are subject to risks and uncertainties that could cause actual performance or results to differ materially from those expressed in the forward-looking statements. For a more detailed description of the risks and uncertainties affecting the Company, reference is made to the Company's reports filed from time to time with the Securities and Exchange Commission ("SEC"), including, but not limited to, the risks detailed in the Company's Annual Report on Form 20-F filed on March 5, 2021. Forward-looking statements speak only as of the date the statements are made. The Company assumes no obligation to update forward-looking statements to reflect actual results, subsequent events or circumstances, changes in assumptions or changes in other factors affecting forward-looking information except to the extent required by applicable securities laws. If the Company does update one or more forward-looking statements, no inference should be drawn that the Company will make additional updates with respect thereto or with respect to other forward-looking statements.

    References and links to websites have been provided as a convenience, and the information contained on such websites is not incorporated by reference into this press release. PolyPid is not responsible for the contents of third-party websites.

    Corporate Contact

    PolyPid, Ltd.

    Dikla Czaczkes Akselbrad

    EVP & CFO

    Tel: +972-747195700

    Investor Contact

    Bob Yedid

    LifeSci Advisors

    646-597-6989



    Media Contact

    Nechama Feuerstein

    551-444-0784





    Primary Logo

    View Full Article Hide Full Article
View All PolyPid Ltd. News