PYPD PolyPid Ltd.

10.48
+0.13  (+1%)
Previous Close 10.35
Open 10.4
52 Week Low 8.6399
52 Week High 19.45
Market Cap $193,820,725
Shares 18,494,344
Float 13,169,432
Enterprise Value $147,671,460
Volume 92,668
Av. Daily Volume 55,428
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Upcoming Catalysts

Drug Stage Catalyst Date
D-PLEX100 - SHILED I
Abdominal (soft tissue) sternal surgical site infections
Phase 3
Phase 3
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Drug Pipeline

Drug Stage Notes
D-PLEX100 (SHIELD II)
Surgical Site Infection
Phase 3
Phase 3
Phase 3 trial initiation announced December 16, 2020.
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. Single Local Treatment of OncoPLEX Showed Improved Overall Survival and Significantly Less Tumor Recurrence, and Reduced Systemic Toxicity Compared to Multiple Injections with Standard Systemic Chemotherapy in a Syngeneic Mouse Model for Solid Tumors of Colon Carcinoma

    Company Intends to Complete an IND Package with Additional Preclinical Studies in Various Solid Tumor Types, Followed by the Initiation of a Phase 1 Clinical Trial in 2022

    PETAH TIKVA, Israel, Dec. 22, 2020 (GLOBE NEWSWIRE) -- PolyPid Ltd. (NASDAQ:PYPD), a Phase 3 clinical-stage biopharmaceutical company focused on developing targeted, locally administered and prolonged-release therapeutics using its proprietary PLEX technology, today announced positive preclinical data from…

    Single Local Treatment of OncoPLEX Showed Improved Overall Survival and Significantly Less Tumor Recurrence, and Reduced Systemic Toxicity Compared to Multiple Injections with Standard Systemic Chemotherapy in a Syngeneic Mouse Model for Solid Tumors of Colon Carcinoma

    Company Intends to Complete an IND Package with Additional Preclinical Studies in Various Solid Tumor Types, Followed by the Initiation of a Phase 1 Clinical Trial in 2022

    PETAH TIKVA, Israel, Dec. 22, 2020 (GLOBE NEWSWIRE) -- PolyPid Ltd. (NASDAQ:PYPD), a Phase 3 clinical-stage biopharmaceutical company focused on developing targeted, locally administered and prolonged-release therapeutics using its proprietary PLEX technology, today announced positive preclinical data from its OncoPLEX intra-tumoral cancer therapy program. OncoPLEX utilizes the Company's novel PLEX technology to provide prolonged and controlled local exposure to docetaxel, one of the most widely used chemotherapy agents, in the intra-operative tumor resection setting. OncoPLEX is designed for the delivery of sustained, significant concentrations of docetaxel locally within the tumor site for a few weeks, potentially reducing local tumor recurrence and tumor metastatic spreading.

    In a syngeneic mouse model for solid tumors of colon carcinoma, a single local application of OncoPLEX at the intra-operative setting post tumor resection compared to the group treated with six cycles of systemic docetaxel treatment with 2-4 days gap between cycles, generated the following key results:

    • OncoPLEX arm showed 25% overall tumor recurrence at the end of the study (day 39 post-surgery) compared to 75% in the systemic treatment arm, and 100% in the untreated control arm.
    • OncoPLEX arm demonstrated 75% overall tumor free survival at the end of the study (day 39 post-surgery), compared to 25% in the systemic treatment arm, and 0% in the untreated control arm.
    • OncoPLEX arm demonstrated 75% overall survival at the end of the study (day 39 post-surgery), compared to 50% in the systemic treatment arm, and 0% in the untreated control arm.

    Dose response was also demonstrated for OncoPLEX in these studies.

    Systemic toxicity was lower following the local application of OncoPLEX versus systemic docetaxel. Additional data in a pharmacokinetic model showed that the maximal plasma concentration of docetaxel was >10 times lower with OncoPLEX than with systemic docetaxel.

    "We believe the benefits of our PLEX platform, including the ability to generate constant and high local concentration of drug over a prolonged period, can also potentially be leveraged as an anti-cancer therapy," said Dr. Noam Emanuel, PolyPid's Chief Scientific Officer. "We are very encouraged by these preclinical data, as they support our belief that direct local application of OncoPLEX in the intra-operative tumor resection setting has the potential to be a promising new type of adjuvant therapy to reduce local tumor recurrence and to prevent postoperative metastatic spreading by cancer cells that escape resection, as seen in many oncology patients across different solid tumors."

    Based on these compelling preclinical results, PolyPid intends to conduct additional preclinical safety studies of OncoPLEX in various type of solid tumor resections, in order to complete a preclinical package for the filing of pre-Investigational New Drug meeting request with the U.S. Food and Drug Administration in 2021 and potentially initiate a Phase 1 clinical trial in 2022.

    About PolyPid

    PolyPid is a Phase 3 clinical-stage biopharmaceutical company focused on developing targeted, locally administered and prolonged-release therapeutics using its proprietary PLEX (Polymer-Lipid Encapsulation matriX) technology. PolyPid's product candidates are designed to address diseases with high unmet medical needs by pairing PLEX with drugs to deliver them directly to precise sites in the body at predetermined release rates and over durations ranging from several days to several months. PolyPid's lead product candidate, D-PLEX100, is in Phase 3 clinical trials for the prevention of sternal SSIs and abdominal SSIs. PolyPid's technology and products are based on the inventions and the professional leadership of Dr. Noam Emanuel, the Founder and the Chief Scientific Officer of the company.

    For additional company information, visit www.polypid.com.

    Forward-looking Statements

    This press release contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995 and other Federal 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, PolyPid is using forward-looking statements in this press release when it discusses the potential of its products and that it intends to conduct additional preclinical safety studies of OncoPLEX in various type of solid tumor resections, in order to complete a preclinical package for the filing of pre-Investigational New Drug meeting request with the U.S. Food and Drug Administration in 2021 and potentially initiate a Phase 1 clinical trial in 2022. Actual results, performance or achievements of PolyPid could differ materially from those described in or implied by the statements in this press release. The forward-looking statements contained or implied in this press release are subject to other risks and uncertainties, including those discussed under the heading "Risk Factors" in PolyPid's final prospectus dated June 25, 2020, filed pursuant to Rule 424(b)(4) with the Securities and Exchange Commission (SEC), and in any subsequent filings with the SEC. Except as otherwise required by law, PolyPid undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. 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.

     



    Company contact:
    
    PolyPid, Ltd. 
    Dikla Czaczkes Akselbrad
    EVP & CFO
    Tel: +972-747195700
    
    
    Investors contact: 
    
    Bob Yedid
    LifeSci Advisors
    646-597-6989
    

    Primary Logo

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  2. Enrollment in SHIELD I, the First Phase 3 Clinical Trial Continues to Progress, with Top-line Data Anticipated in Second Half of 2021

    PETAH TIKVA, Israel, Dec. 16, 2020 (GLOBE NEWSWIRE) -- PolyPid Ltd. (NASDAQ:PYPD), a Phase 3 clinical-stage biopharmaceutical company focused on developing targeted, locally administered and prolonged-release therapeutics using its proprietary PLEX technology, today announced that the first patient has been enrolled and randomized in the SHIELD II (Surgical site Hospital acquired Infection prEvention with Local D-plex) trial, the Company's second of two Phase 3 clinical trials for its lead product candidate, D-PLEX100, for the prevention of post-abdominal surgery incisional infection (soft tissue).

    "Three…

    Enrollment in SHIELD I, the First Phase 3 Clinical Trial Continues to Progress, with Top-line Data Anticipated in Second Half of 2021

    PETAH TIKVA, Israel, Dec. 16, 2020 (GLOBE NEWSWIRE) -- PolyPid Ltd. (NASDAQ:PYPD), a Phase 3 clinical-stage biopharmaceutical company focused on developing targeted, locally administered and prolonged-release therapeutics using its proprietary PLEX technology, today announced that the first patient has been enrolled and randomized in the SHIELD II (Surgical site Hospital acquired Infection prEvention with Local D-plex) trial, the Company's second of two Phase 3 clinical trials for its lead product candidate, D-PLEX100, for the prevention of post-abdominal surgery incisional infection (soft tissue).

    "Three weeks after D-PLEX100 received Breakthrough Therapy Designation from the FDA, the enrollment of the first patient in our second Phase 3 trial is a significant achievement for our D-PLEX100 clinical development program. Importantly, SHIELD II will have broader eligibility criteria than SHIELD I, with the inclusion of minimally invasive surgical procedures, providing additional clinical evaluation of the potential of D-PLEX100 to prevent surgical site infections (SSIs) in broader target populations," said Amir Weisberg, PolyPid's CEO. "Enrollment in our first Phase 3 clinical trial, SHIELD I, continues to progress as expected and we anticipate the availability of top-line results from this study in the second half of next year. SHIELD I and SHIELD II will serve as the basis for our first New Drug Application submission."

    "Based on the compelling data generated to date, D-PLEX100, if approved, has the potential to be a highly effective solution in preventing SSIs, even in the most complex surgical settings such as abdominal surgery with colorectal resection," said Anthony Senagore, M.D., a leading colorectal surgeon, and a medical advisor to PolyPid. "As systemic antibiotic penetration into the surgical wound is significantly limited due to blood flow interruption, a substantial unmet need remains in preventing SSIs. I look forward to the continued clinical assessment of this promising therapeutic candidate in the SHIELD I and SHIELD II studies."

    SHIELD II (NCT04411199) is a prospective, multinational, multicenter, randomized, double-blind Phase 3 trial designed to assess the efficacy and safety of D-PLEX100 administered concomitantly with the Standard of Care (SoC), compared to a SoC-treated control arm, for the prevention of post-abdominal surgery incisional infection. The primary endpoint of the trial is the infection rate, as measured by the proportion of subjects with at least one abdominal target incisional infection event within 30 days post-abdominal surgery, determined by a blinded independent adjudication committee. The trial will enroll a minimum of 900 patients, with a maximum of approximately 1,400 subjects, as defined by the adaptive study design, in approximately 60 centers in the United States, Europe and Israel.

    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 is a Phase 3 clinical-stage biopharmaceutical company focused on developing targeted, locally administered and prolonged-release therapeutics using its proprietary PLEX (Polymer-Lipid Encapsulation matriX) technology. PolyPid's product candidates are designed to address diseases with high unmet medical needs by pairing PLEX with drugs to deliver them directly to precise sites in the body at predetermined release rates and over durations ranging from several days to several months. PolyPid's lead product candidate, D-PLEX100, is in Phase 3 clinical trials for the prevention of sternal SSIs and abdominal SSIs. PolyPid's technology and products are based on the inventions and the professional leadership of Dr. Noam Emanuel, the Founder and the Chief Scientific Officer of the company.

    For additional company information, visit www.polypid.com

    Forward-looking Statements

    This press release contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995 and other Federal 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, PolyPid is using forward-looking statements in this press release when it discusses the potential of D-PLEX100 to prevent SSIs, and the enrollment and timing of clinical trials. Because such statements deal with future events and are based on PolyPid's current expectations, they are subject to various risks and uncertainties. Also, while PolyPid has received Fast Track Designation for D-PLEX100 for the prevention of SSIs, it cannot guarantee that it will be able to maintain such designation due to reasons within our outside of its control. Actual results, performance or achievements of PolyPid could differ materially from those described in or implied by the statements in this press release. The forward-looking statements contained or implied in this press release are subject to other risks and uncertainties, including those discussed under the heading "Risk Factors" in PolyPid's final prospectus dated June 25, 2020, filed pursuant to Rule 424(b)(4) with the Securities and Exchange Commission (SEC), and in any subsequent filings with the SEC. Except as otherwise required by law, PolyPid undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. 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.

     



    Company contact:
    
    PolyPid, Ltd. 
    Dikla Czaczkes Akselbrad
    EVP & CFO
    Tel: +972-747195700
    
    
    Investors contact: 
    
    Bob Yedid
    LifeSci Advisors
    646-597-6989
    

    Primary Logo

    View Full Article Hide Full Article
  3. PETAH TIKVA, Israel, Dec. 03, 2020 (GLOBE NEWSWIRE) -- PolyPid Ltd. (NASDAQ:PYPD), a Phase 3 clinical-stage biopharmaceutical company focused on developing targeted, locally administered, and prolonged-release therapeutics using its proprietary PLEX technology, today announced that it will host a key opinion leader (KOL) call on D-PLEX100 for the prevention of surgical site infections on Tuesday, December 15, 2020, at 8:00 am Eastern Time.

    The call will feature presentations by KOLs Hartzell V. Schaff, MD, Mayo Clinic, Anthony J. Senagore, MD, Formerly of UTMB at Galveston, and Oded Zmora, MD, Shamir Medical Center, Israel, who will discuss the burden and challenges related to surgical site infections (SSIs) post colorectal and cardiovascular…

    PETAH TIKVA, Israel, Dec. 03, 2020 (GLOBE NEWSWIRE) -- PolyPid Ltd. (NASDAQ:PYPD), a Phase 3 clinical-stage biopharmaceutical company focused on developing targeted, locally administered, and prolonged-release therapeutics using its proprietary PLEX technology, today announced that it will host a key opinion leader (KOL) call on D-PLEX100 for the prevention of surgical site infections on Tuesday, December 15, 2020, at 8:00 am Eastern Time.

    The call will feature presentations by KOLs Hartzell V. Schaff, MD, Mayo Clinic, Anthony J. Senagore, MD, Formerly of UTMB at Galveston, and Oded Zmora, MD, Shamir Medical Center, Israel, who will discuss the burden and challenges related to surgical site infections (SSIs) post colorectal and cardiovascular surgeries and the opportunity for D-PLEX100 to change the current status quo for the better. Dr. Schaff, Dr. Senagore, and Dr. Zmora will be available to answer questions following the formal presentations.

    PolyPid's management team will also discuss its developmental plans for D-PLEX100.

    To register for the call, please register here.

    Dr. Schaff is the Stuart W. Harrington Professor of Surgery and a consultant in the Division of Cardiovascular Surgery at Mayo Clinic, Rochester, Minnesota. He is a member of major international societies, including the American Association for Thoracic Surgery (2012-2013 President). He has authored or co-authored 784 papers, 94 book chapters, edited or written nine textbooks, and delivered over 500 lectures. He has served or is serving on the editorial boards of 11 journals, including Circulation and the Journal of Thoracic and Cardiovascular Surgery, where he is currently the Associate Editor. Dr. Schaff received his medical degree and training at the University of Oklahoma School of Medicine, where he also completed an NIH Research Fellowship. His surgical training was completed at Johns Hopkins Hospital.

    Anthony J. Senagore, MD, is a colorectal surgeon with a long track record of academic surgery practice. He now serves as the Chief Strategy Officer for Genetesis in Mason, Ohio, and consults several healthcare startup companies. He has served as Professor of Surgery at several prestigious academic medical centers, including UTMB (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. He has served as Chair of the Colorectal Surgery Residency Review Committee for the ACGME, President of the Board of Colon and Rectal Surgery, and he is a Past President of the ASCRS 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. He 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 continued his education and 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. He has edited five textbooks in colon and rectal surgery, authored over 230 peer-reviewed publications and 25 textbook chapters.

    Oded Zmora, MD is a Colon and Rectal Surgeon and Chair of the Department of Surgery, Shamir Medical Center, Israel. He is also an associate professor of surgery at the Tel Aviv University School of Medicine. Dr. Zmora's education and training include residency in general surgery at the Sheba Medical Center in Israel and the Mount Sinai Medical Center in New York, followed by two years of clinical and research fellowships at the Cleveland Clinic, Florida. Dr. Zmora is a past president of the Israel Society of Colon and Rectal Surgeons, immediate past chair of the S-ECCO (Surgeons' European Crohn and Colitis Organization), and past co-editor of Techniques in Coloproctology. His main research interests focus on colorectal surgery, including surgical infectious complications, prevention of colorectal cancer metastases, treatment of perineal fistulas, and clinical research in colon and rectal surgery.

    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 treat antibiotic-resistant bacteria at the surgical site. D-PLEX100 has received Breakthrough Therapy Designation from the FDA for the prevention of surgical site infections (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 is a Phase 3 clinical-stage biopharmaceutical company focused on developing targeted, locally administered and prolonged-release therapeutics using its proprietary PLEX (Polymer-Lipid Encapsulation matriX) technology. PolyPid's product candidates are designed to address diseases with high unmet medical needs by pairing PLEX with drugs to deliver them directly to precise sites in the body at predetermined release rates and over durations ranging from several days to several months. PolyPid's lead product candidate, D-PLEX100, is in Phase 3 clinical trials for the prevention of sternal SSIs and abdominal SSIs. PolyPid's technology and products are based on the inventions and the professional leadership of Dr. Noam Emanuel, the Founder and the Chief Scientific Officer of the company.

    For additional company information, visit www.polypid.com.

    Forward-looking Statements

    This press release contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995 and other Federal 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, PolyPid is using forward-looking statements in this press release when it discusses its development and commercial plans for D-PLEX100 and Phase 3 trials of D-PLEX100. Because such statements deal with future events and are based on PolyPid's current expectations, they are subject to various risks and uncertainties. Actual results, performance or achievements of PolyPid could differ materially from those described in or implied by the statements in this press release. The forward-looking statements contained or implied in this press release are subject to other risks and uncertainties, including those discussed under the heading "Risk Factors" in PolyPid's final prospectus dated June 25, 2020, filed pursuant to Rule 424(b)(4) with the Securities and Exchange Commission ("SEC"), and in any subsequent filings with the SEC. Except as otherwise required by law, PolyPid undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. 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.



    Company contact:
    
    PolyPid, Ltd. 
    Dikla Czaczkes Akselbrad
    EVP & CFO
    Tel: +972-747195700 
    
    
    Investors contact:
    
    Bob Yedid
    LifeSci Advisors
    646-597-6989
    

    Primary Logo

    View Full Article Hide Full Article
  4. PETAH TIKVA, Israel, Nov. 24, 2020 (GLOBE NEWSWIRE) -- PolyPid Ltd. (NASDAQ:PYPD), a Phase 3 clinical-stage biopharmaceutical company focused on developing targeted, locally administered and prolonged-release therapeutics using its proprietary PLEX technology, today announced that D-PLEX100 has received Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA) for the prevention of surgical site infections (SSIs) in patients undergoing elective colorectal surgery.

    Breakthrough Therapy Designation is an FDA process designed to expedite the development and review of drugs that are intended to treat a serious or life-threatening condition so patients may have access to therapies through FDA approval as soon as possible…

    PETAH TIKVA, Israel, Nov. 24, 2020 (GLOBE NEWSWIRE) -- PolyPid Ltd. (NASDAQ:PYPD), a Phase 3 clinical-stage biopharmaceutical company focused on developing targeted, locally administered and prolonged-release therapeutics using its proprietary PLEX technology, today announced that D-PLEX100 has received Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA) for the prevention of surgical site infections (SSIs) in patients undergoing elective colorectal surgery.

    Breakthrough Therapy Designation is an FDA process designed to expedite the development and review of drugs that are intended to treat a serious or life-threatening condition so patients may have access to therapies through FDA approval as soon as possible. This designation is granted based on preliminary clinical evidence indicating that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints.

    "The Breakthrough Therapy Designation in the field of anti-infective drugs is rather rare, and further supports the urgency to develop new innovative therapies to prevent SSIs," said Amir Weisberg, PolyPid's CEO. "It also reflects on the promising clinical data of D-PLEX100 in the prevention of SSIs in complex surgical settings, such as colorectal abdominal surgeries. We are looking forward to working closely with the FDA to make D-PLEX100 available to surgeons and patients as quickly as possible. Our ongoing Phase 3 pivotal studies in abdominal surgery - SHIELD I and SHIELD II - are on track."

    The Breakthrough Therapy Designation for D-PLEX100 is based on conclusive positive results from a Phase 2 clinical trial evaluating D-PLEX100 for the prevention of surgical site infections (SSIs) in abdominal colorectal surgery. The Phase 2 clinical trial was a prospective, multicenter, randomized, controlled two arm study in 201 patients and demonstrated that the local administration of D-PLEX100 resulted in a statistically significant decrease in SSIs of 59 percent in the Intent to Treat (ITT) population (p=0.0086), and a decrease of 69 percent in the Per Protocol population (n=179; p=0.0024), as compared to the standard of care alone.

    D-PLEX100 previously received two Fast Track Designations from the FDA for the prevention of post-abdominal surgery incisional infections and for the prevention of sternal wound infections post-cardiac surgery, as well as two Qualified Infectious Disease Product designations (QIDP's) in the same indications.

    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 treat antibiotic-resistant bacteria at the surgical site. D-PLEX100 has received two Qualified Infectious Disease Product (QIDP) designations as well as two Fast Track designations from the FDA for the prevention of post-abdominal surgery incisional infection and for the prevention of sternal wound infection post-cardiac surgery.

    About PolyPid

    PolyPid is a Phase 3 clinical-stage biopharmaceutical company focused on developing targeted, locally administered and prolonged-release therapeutics using its proprietary PLEX (Polymer-Lipid Encapsulation matriX) technology. PolyPid's product candidates are designed to address diseases with high unmet medical needs by pairing PLEX with drugs to deliver them directly to precise sites in the body at predetermined release rates and over durations ranging from several days to several months. PolyPid's lead product candidate, D-PLEX100, is in Phase 3 clinical trials for the prevention of sternal SSIs and abdominal SSIs. PolyPid's technology and products are based on the inventions and the professional leadership of Dr. Noam Emanuel, the Founder and the Chief Scientific Officer of the company.

    For additional company information, visit www.polypid.com.

    Forward-looking Statements

    This press release contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995 and other Federal 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, PolyPid is using forward-looking statements in this press release when it discusses the potential of D-PLEX100 to prevent SSIs, timing, subject matter and frequency of communications with the FDA, and providing a safe and effective solution for surgeons and their patients as quickly as possible. Because such statements deal with future events and are based on PolyPid's current expectations, they are subject to various risks and uncertainties. Also, while PolyPid has received Fast Track Designation for D-PLEX100 for the prevention of surgical site infections, and Breakthrough Therapy Designation for the prevention of SSIs in colorectal surgery, it cannot guarantee that it will be able to maintain such designation due to reasons within our outside of its control. Actual results, performance or achievements of PolyPid could differ materially from those described in or implied by the statements in this press release. The forward-looking statements contained or implied in this press release are subject to other risks and uncertainties, including those discussed under the heading "Risk Factors" in PolyPid's final prospectus dated June 25, 2020, filed pursuant to Rule 424(b)(4) with the Securities and Exchange Commission ("SEC"), and in any subsequent filings with the SEC. Except as otherwise required by law, PolyPid undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. 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.



    Company contact:
    
    PolyPid, Ltd. 
    Dikla Czaczkes Akselbrad
    EVP & CFO
    Tel: +972-747195700
    
    Investors contact: 
    
    Bob Yedid
    LifeSci Advisors
    646-597-6989
    

    Primary Logo

    View Full Article Hide Full Article
  5. •  Over 50% of planned 60 centers for ongoing Phase 3 SHIELD I trial of D-PLEX100in abdominal surgery have received IRB approval 

    •  Phase 3 SHIELD II trial advanced; preparations underway to initiate by year-end 2020

    •  Conference Call Scheduled for today at 8:30 a.m. ET

    PETAH TIKVA, Israel, Nov. 11, 2020 (GLOBE NEWSWIRE) -- PolyPid Ltd. (NASDAQ:PYPD) (the "Company"), a Phase 3 clinical-stage biopharmaceutical company focused on developing targeted, locally administered and prolonged-release therapeutics using its proprietary PLEX technology, today provided a corporate update and reported financial results for the three and nine months ended September 30, 2020.

    Recent Corporate Highlights:

    • Over 50% of planned 60 centers have…

    •  Over 50% of planned 60 centers for ongoing Phase 3 SHIELD I trial of D-PLEX100 in abdominal surgery have received IRB approval 

    •  Phase 3 SHIELD II trial advanced; preparations underway to initiate by year-end 2020

    •  Conference Call Scheduled for today at 8:30 a.m. ET

    PETAH TIKVA, Israel, Nov. 11, 2020 (GLOBE NEWSWIRE) -- PolyPid Ltd. (NASDAQ:PYPD) (the "Company"), a Phase 3 clinical-stage biopharmaceutical company focused on developing targeted, locally administered and prolonged-release therapeutics using its proprietary PLEX technology, today provided a corporate update and reported financial results for the three and nine months ended September 30, 2020.

    Recent Corporate Highlights:

    • Over 50% of planned 60 centers have received institutional review board (IRB) approval for ongoing Phase 3 SHIELD I (Surgical site Hospital-acquired Infection PrEvention with Local D-plex) trial for D-PLEX100 in abdominal surgery (soft tissue). This is the first of two planned Phase 3 clinical trials of D-PLEX100, the Company's lead product candidate for the prevention of surgical site infections (SSIs) in abdominal surgery (soft tissue). The Company plans to enroll 600 - 900 patients undergoing high priority operations in 60 centers in the United States, Europe, and Israel. Following the enrollment of approximately 500 patients, the study design provides for a blinded sample size re-estimation.



    • Advanced preparations are underway to initiate SHIELD II, a second Phase 3 trial for D-PLEX100 in abdominal surgery, by year-end 2020. This second trial will have broader eligibility criteria, including minimally invasive surgical procedures, and will enroll approximately 900 - 1,400 patients across approximately 60 centers.



    • Evaluating EU commercial partnership opportunities for D-PLEX100 as part of the Company's stated commercial strategy.

    "We are very encouraged with our strong progress to date, especially readying additional sites to enroll patients in our lead Phase 3 trial, and remain on track for our planned milestones," said Amir Weisberg, Chief Executive Officer. "We continue to anticipate that top-line results from SHIELD I will be available in the second half of 2021. Moreover, we expect that the initiation of our second Phase 3 pivotal trial, SHIELD II, will occur in late 2020. SHIELD I and SHIELD II will serve as the basis for PolyPid's first New Drug Application (NDA) submission and, we believe, will support a broad label for D-PLEX100 in the prevention of SSIs."

    "We continue to operate from a strong financial position," continued Mr. Weisberg. "We expect that our current cash balance will be sufficient to complete SHIELD I and to initiate and conduct SHIELD II, as well as prepare for the submission of an NDA to the U.S. Food and Drug Administration."

    Financial results for three months ended September 30, 2020

    • Research and development (R&D) expenses for the three months ended September 30, 2020 were $4.2 million, compared to $3.8 million in the same three-month period of 2019, as spending increased due to the initiation of the Phase 3 SHIELD I clinical trial and preparations for the Phase 3 SHIELD II clinical trial.



    • General and administrative (G&A) expenses for the three months ended September 30, 2020 were $2.2 million, compared to $1.2 million for the same period of 2019, as costs increased due to becoming a publicly-traded company with higher D&O insurance costs and due to an increase in non-cash share-based compensation.



    • For the three months ended September 30, 2020, the Company had a net loss attributable to ordinary shares of $6.5 million, compared to a net loss of $2.1 million in the three-month period ended September 30, 2019.

    Financial results for nine-months ended September 30, 2020

    • R&D expenses for the nine months ended September 30, 2020 were $11.9 million, compared to $10.8 million in the same nine-month period of 2019, as spending increased due to the initiation of the Phase 3 SHIELD I clinical trial and preparations for the Phase 3 SHIELD II clinical trial.



    • G&A expenses for the nine months ended September 30, 2020 were $5.5 million, compared to $2.8 million for the same nine-month period of 2019, as costs increased due to becoming a publicly-traded company with higher D&O insurance costs and due to an increase in non-cash share-based compensation.



    • For the nine months ended September 30, 2020, the Company had a net loss attributable to ordinary shares of $31.4 million, compared to a net loss of $3.0 million, for the nine-month period ended September 30, 2019.

    Balance Sheet Highlights

    • As of September 30, 2020, the Company had cash and cash equivalents, short-term deposits and long-term deposits in the amount of $71.8 million, compared to $26.6 million as of December 31, 2019. This increase reflects the completion of the Company's IPO in June 2020, which raised net proceeds of $62.8 million, after underwriting fees and offering expenses. PolyPid expects that this cash balance will be sufficient to fund operations into 2022.

    Conference Call Dial-In & Webcast Information

    Wednesday, November 11th at 8:30 am Eastern Time

     United States:+1 877 870 9135
     Israel:+972 1809 213-985
     International:+44 (0) 2071 928338
     Conference ID:4557195
     Webcast:https://edge.media-server.com/mmc/p/u49mfor4
       

    About D-PLEX100

    PolyPid's lead product candidate, D-PLEX100, is a novel product candidate designed to provide local prolonged 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 up to four weeks for the prevention of SSIs, with additional potential to treat antibiotic-resistant bacteria at the surgical site. D-PLEX100 has received two Qualified Infectious Disease Product (QIDP) designations, as well as two Fast Track designations from the FDA for the prevention of post-abdominal surgery incisional infection and for the prevention of sternal wound infection post-cardiac surgery.

    About PolyPid

    PolyPid is a Phase 3 clinical-stage biopharmaceutical company focused on developing targeted, locally administered and prolonged-release therapeutics using its proprietary PLEX (Polymer-Lipid Encapsulation matriX) technology. PolyPid's product candidates are designed to address diseases with high unmet medical needs by pairing PLEX with drugs to deliver them directly to precise sites in the body at predetermined release rates and over durations ranging from several days to several months. PolyPid's lead product candidate, D-PLEX100, is in Phase 3 clinical trials for the prevention of SSIs in different type of surgeries, including abdominal and open-heart surgery. PolyPid's technology and products are based on the inventions of Dr. Noam Emanuel, the Founder and the Chief Scientific Officer of the company.

    For additional company information, visit www.polypid.com.

    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 statements relating to its objectives, milestones, plans, and strategies, the expected timing of trials and release of the results thereof, the expected timing of an NDA and other regulatory matters, the research, development, the sufficiency of the Company's cash and use of the Company's platform technologies, technologies, products and product candidates, and all statements (other than statements of historical facts) that address activities, events, or developments that the Company intends, expects, projects, believes, or anticipates will or may occur in the future. 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 prospectus filed pursuant to Rule 424(b)(4), filed with the SEC on June 29, 2020. 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.



         
    CONSOLIDATED BALANCE SHEETS
    U.S. dollars in thousands
         
      September 30,

    2020
     December 31,

    2019
      Unaudited Audited
    ASSETS    
         
    CURRENT ASSETS:    
    Cash and cash equivalents $9,665  $3,924 
    Restricted cash  378   375 
    Short-term deposits  34,080   22,685 
    Prepaid expenses and other receivables  2,504   417 
         
    Total current assets  46,627   27,401 
         
    LONG-TERM ASSETS:    
    Property and equipment, net  6,182   6,121 
    Long-term deposits  28,068   - 
    Other long-term assets  221   230 
         
    Total long-term assets  34,471   6,351 
         
    Total assets $81,098  $33,752 
             







         
    CONSOLIDATED BALANCE SHEETS
    U.S. dollars in thousands (except share and per share data)
         
      September 30,

    2020
     December 31,

    2019
      Unaudited Audited
    LIABILITIES, CONVERTIBLE PREFERRED SHARES AND SHAREHOLDERS' DEFICIENCY    
         
    CURRENT LIABILITIES:    
    Trade payables $573  $1,581 
    Other payables and accrued expenses  1,112   998 
         
    Total current liabilities  1,685   2,579 
         
    LONG-TERM LIABILITIES:    
    Other liabilities  180   251 
    Convertible preferred shares warrant liability  -   12,241 
         
    Total long-term liabilities  180   12,492 
         
    COMMITMENTS AND CONTINGENT LIABILITIES    
         
    CONVERTIBLE PREFERRED SHARES:        
    Preferred A, A-1, B, B-1, C-1, C-2, D-1, D-3, E and E-1 shares of NIS 0 par value - Authorized: 0 and 17,916,412 shares at September 30, 2020 (unaudited) and December 31, 2019, respectively; Issued and outstanding: 0 and 12,520,977 shares at September 30, 2020 (unaudited) and December 31, 2019, respectively  -   106,313 
         
    SHAREHOLDERS' EQUITY (DEFICIENCY):    
    Share capital -    
    Ordinary shares with no par value - Authorized: 47,800,000 and 22,466,000 shares at September 30, 2020 (unaudited) and December 31, 2019, respectively; Issued and outstanding: 18,494,344 and 562,748 shares at September 30, 2020 (unaudited) and December 31, 2019, respectively  -   - 
    Additional paid-in capital  203,970   5,671 
    Accumulated deficit  (124,737)  (93,303)
         
    Total shareholders' equity (deficiency)  79,233   (87,632)
         
    Total liabilities, convertible preferred shares and shareholders' equity (deficiency) $81,098  $33,752 
             





         
    CONSOLIDATED STATEMENTS OF OPERATIONS
    U.S. dollars in thousands
         
      Three months ended

    September 30,
     Nine months ended

    September 30,
       2020   2019   2020  2019 
                    
      Unaudited
             
    Operating expenses:        
    Research and development, net $4,176  $3,789  $11,948 $10,769 
    Marketing and business development expenses  323   274   904  571 
    General and administrative  2,177   1,190   5,532  2,812 
             
    Operating loss  6,676   5,253   18,384  14,152 
    Financial (income) expense, net  (218)  (3,145)  10,936  (11,107)
             
    Net loss (profit) $6,458  $2,108  $29,320 $3,045 
             
    Deemed dividend  -   -   2,114  - 
             
    Net loss (profit) attributable to Ordinary shares $6,458  $2,108  $31,434 $3,045 
             
    Basic and diluted net loss per Ordinary share $0.35  $6.94  $4.78 $13.38 
             
    Weighted average number of Ordinary shares used in computing basic and diluted net loss per share  18,415,231   562,597   6,578,969  562,354 
             













































































































     

    Company contact:
    
    PolyPid, Ltd. 
    Dikla Czaczkes Akselbrad
    EVP & CFO
    Tel: +972-74-719-5700 
    
    
    Investor contact:
    
    Bob Yedid
    LifeSci Advisors
    646-597-6989
    

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